<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714310</url>
  </required_header>
  <id_info>
    <org_study_id>U01MH093582</org_study_id>
    <secondary_id>U01MH093582</secondary_id>
    <nct_id>NCT01714310</nct_id>
  </id_info>
  <brief_title>Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation</brief_title>
  <official_title>Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will characterize children and adolescents with severe mood dysregulation (SMD)&#xD;
      and conduct a pilot study of combination pharmacotherapy as a basis for future intervention&#xD;
      trials.&#xD;
&#xD;
      Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine&#xD;
      (LDX) to optimal dose, followed by double-blind randomization to fluoxetine (N=25) or placebo&#xD;
      (N=25) in combination with optimized LDX for an additional 8 weeks. Participants will be&#xD;
      monitored for clinical response and adverse events.&#xD;
&#xD;
      Specific aims are:&#xD;
&#xD;
      #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive&#xD;
      functioning, and a potential &quot;bio-signature&quot; derived from electroencephalography (EEG).&#xD;
&#xD;
      Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison&#xD;
      to non-SMD individuals in our pre-existing database on patterns of a) psychiatric&#xD;
      comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2)&#xD;
      that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with&#xD;
      SMD.&#xD;
&#xD;
      #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant&#xD;
      followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI)&#xD;
      therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability&#xD;
      of the proposed combination treatment as a basis for future clinical investigations.&#xD;
&#xD;
      Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global&#xD;
      Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident&#xD;
      after open-label LDX titration; 2) that participants randomized to fluoxetine will&#xD;
      demonstrate additional significant improvement in CGI-I-SMD scores and other secondary&#xD;
      measures in comparison to participants randomized to placebo; 3) that combination LDX and&#xD;
      SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      The increased frequency of diagnosed pediatric bipolar disorder has emerged as one of the&#xD;
      greatest controversies in child and adolescent psychiatry. Beginning with reports that 20% of&#xD;
      prepubertal of children with Attention-Deficit/Hyperactivity Disorder (ADHD) met criteria for&#xD;
      juvenile mania, a view arose that bipolar children were more irritable than euphoric and more&#xD;
      chronic than episodic, compared with the typical adult. Concurrently, there was a 4 to 6-fold&#xD;
      increase in inpatient discharges and 40-fold increase in office-based visits for pediatric&#xD;
      bipolar disorder, although many of these failed to meet formal Diagnostic and Statistical&#xD;
      Manual (DSM) criteria. Concerns have been raised that any child with impulsive, volatile&#xD;
      behavior is apt to be diagnosed as bipolar.&#xD;
&#xD;
      Some attempted to inform valid symptomatic boundaries by proposing a differentiation of&#xD;
      narrow versus broad pediatric bipolar phenotypes. The narrow phenotype was defined by strict&#xD;
      DSM criteria for mania or hypomania, including discrete episodes of grandiosity and euphoria.&#xD;
      In contrast, the broad phenotype, also referred to as severe mood dysregulation (SMD), was&#xD;
      defined by chronic, non-episodic illness lacking hallmark symptoms of grandiosity and&#xD;
      euphoria, but typified by severe irritability and hyperarousal. Work at the National&#xD;
      Institute of Mental Health (NIMH) demonstrated that patterns of adolescent irritability are&#xD;
      stable and distinct, with episodic irritability leading to mania and simple phobia, and&#xD;
      chronic irritability leading to diagnosed depression and ADHD. On structured assessment,&#xD;
      children with SMD were highly comorbid for major depression (20%), anxiety (64%),&#xD;
      oppositional defiant disorder (83%), and ADHD (87%). Others also found increased rates of&#xD;
      ADHD and anxiety. In addition, the broad and narrow phenotypes could be differentiated&#xD;
      according to electroencephalography (EEG) measures. SMD youth have impaired face emotion&#xD;
      recognition deficits correlated with dysfunctional family relationships and were less&#xD;
      influenced by emotional distracters during tasks of attention. A recent study revealed&#xD;
      patterns of amygdala hypoactivation similar to depression, further supporting links between&#xD;
      chronic irritability and subsequent depressive episodes.&#xD;
&#xD;
      In response to the perceived over-diagnosis of pediatric DSM bipolar disorder, acknowledgment&#xD;
      that the &quot;classic&quot; adult bipolar phenotype does occur in prepubertal youth, and increased&#xD;
      recognition that SMD is a distinct behavioral and/or biological syndrome, the DSM-5 Child&#xD;
      Disorders Workgroup proposed a new diagnostic category named temper dysregulation disorder&#xD;
      with dysphoria (TDD). Criteria for TDD were largely based on SMD, however, the requirement&#xD;
      for hyperarousal was removed and minor changes were made in age of onset and exclusion&#xD;
      criteria. Unlike SMD, TDD lacks any demonstrated scientific basis or history of prior&#xD;
      research. As such, it seems prudent at this time to continue research on the&#xD;
      better-established SMD category with an expectation that any information derived will have&#xD;
      ready applicability as work on TDD progresses.&#xD;
&#xD;
      One preliminary report suggests that SMD has a lifetime prevalence of 3.3% among those ages&#xD;
      9-19. Recent longitudinal studies further indicate that children with SMD have increased&#xD;
      rates of adult mood and anxiety disorders, substance abuse, suicidality, and poorer overall&#xD;
      functioning. Given this significant morbidity, it is essential that the investigators&#xD;
      increase understanding of children with chronic irritability and affective instability.&#xD;
      Impulsive aggression in childhood has been identified as a significant public health concern&#xD;
      that cuts across currently defined diagnostic categories. These youth demonstrate increased&#xD;
      difficulties with school adjustment, peer interactions, cognitive deficits, problem-solving,&#xD;
      and physical abuse - a developmental trajectory predictive of significant adult dysfunction.&#xD;
&#xD;
      Current community practice emphasizes use of second-generation antipsychotic agents for&#xD;
      children with impulsive aggression. While risperidone has proven effective for irritability&#xD;
      associated with pervasive developmental disorders [25,26] and second-generation&#xD;
      antipsychotics have been effective in pediatric bipolar disorder, these agents are associated&#xD;
      with significant weight gain and other metabolic effects. Use of these medications is&#xD;
      associated with decreased utilization of psychosocial interventions. Given the relationship&#xD;
      of SMD with ADHD, anxiety, and unipolar depression, investigations of drugs from other&#xD;
      classes with targeted effects and better side effect profiles, such as mood stabilizers,&#xD;
      antidepressants, and stimulants, are certainly warranted. In fact, the DSM-5 Workgroup has&#xD;
      specifically called for clinical trials stating it is &quot;critically important&quot; to assess&#xD;
      whether stimulants and SSRIs should be first line treatments in SMD-affected youth. The only&#xD;
      published medication trial in SMD youth is a double-blind placebo controlled study of lithium&#xD;
      conducted by the intramural group at NIMH, which failed to demonstrate effects. Other&#xD;
      informative investigations include small positive studies of methylphenidate versus placebo&#xD;
      for ADHD plus oppositional defiant disorder and aggression, open-label stimulant followed by&#xD;
      adjuvant divalproex vs. placebo for ADHD and aggression, and stimulant augmentation with&#xD;
      double-blind risperidone versus placebo in ADHD with treatment resistant aggression. These&#xD;
      studies are notably heterogeneous in design and choice of outcome measures. No clear&#xD;
      predictors of response have been reported.&#xD;
&#xD;
      Most existing SMD research has been conducted by a single intramural group at NIMH. It is&#xD;
      imperative that investigations of SMD be expanded to other research groups to ensure that&#xD;
      results generalize to broad clinical settings. Additional research is required to delineate&#xD;
      clinical phenomenology that will inform subsequent efforts at diagnostic classification.&#xD;
      Further work is also necessary to establish the appropriate foundation for future clinical&#xD;
      interventions research. This should include pilot studies of various medication classes that&#xD;
      might prove useful in management of SMD, as well as examination of various outcome measures&#xD;
      that are likely to be useful in both medication and psychosocial intervention trials.&#xD;
&#xD;
      Overview&#xD;
&#xD;
      The study will include comprehensive phenotyping of 65 patients meeting criteria for SMD,&#xD;
      including assessment of comorbid psychopathology, language disorder, neurocognition, and EEG.&#xD;
      Potential endophenotypes and diagnostic boundaries will be assessed in relation to our large&#xD;
      existing database of children and adolescents with internalizing and externalizing disorders,&#xD;
      as well as non-clinical controls. Eligible participants with SMD will proceed to a pilot&#xD;
      study of sequential pharmacotherapy with an initial 4-week titration of open label&#xD;
      lisdexamfetamine (LDX) followed by 8 weeks adjunctive therapy with randomized fluoxetine or&#xD;
      placebo. Statistical analyses will address diagnostic boundaries of SMD compared with other&#xD;
      disorders and emphasize initial determinations of the potential efficacy and tolerability of&#xD;
      stimulant and SSRI treatments for SMD. There will be an added emphasis on effect size&#xD;
      estimates and determination of optimal outcome measures in anticipation of future large-scale&#xD;
      studies.&#xD;
&#xD;
      Project Visits and Procedures&#xD;
&#xD;
      Following baseline visit (week 0), eligible participants will undergo undergo open-label&#xD;
      stepwise titration with one week each of low, medium, and high dose LDX during study weeks 1,&#xD;
      2, and 3. The study physician may modify titration due to emergent side effects following&#xD;
      routine practice standards.&#xD;
&#xD;
      At the end of study week 3, the clinician will determine &quot;optimal&quot; stimulant dose based on&#xD;
      review of parent and teacher-completed Conners Global Index scales and all available adverse&#xD;
      event and side effects data, using procedures similar to those used in other studies.&#xD;
      Participants will remain on this optimal stimulant dose for the remainder of the study,&#xD;
      unless side effects necessitate some downward dose adjustment.&#xD;
&#xD;
      At study week 4, participants who fail to achieve CGI-I-SMD score &lt; 4 will be randomized to&#xD;
      double blind adjunctive treatment with either fluoxetine or placebo.&#xD;
&#xD;
      A forced dose, stepwise, upward titration of one week each of 5, 10, and 20 mg&#xD;
      fluoxetine/placebo will occur at during week 5, 6, and 7. The treating physician may modify&#xD;
      this titration schedule in response to emergent side effect following routine practice&#xD;
      standards. Participants will remain on their week 7 doses of fluoxetine/placebo until the&#xD;
      study's final visit, unless side effects necessitate some downward titration.&#xD;
&#xD;
      Side effects, adverse events, and medication compliance will be assessed at each visit. Major&#xD;
      outcome assessments will occur at baseline (week 0) , end of week 4, and end of week 12.&#xD;
&#xD;
      Arrangements will be made to transfer participants to standard clinical care following week&#xD;
      12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Initial arm for open-label titration of lisdexamfetamine followed by randomization of participants who retain eligibility to double blind adjunctive fluoxetine or placebo.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impression-Severity-Severe Mood Dysregulation</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADHD-IV Rating Scale</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners Parent Global Index</measure>
    <time_frame>Baseline through week 3.</time_frame>
    <description>Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners Global Index Emotional Lability Subscale - Parent Report</measure>
    <time_frame>Baseline to week 3.</time_frame>
    <description>A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners Global Index Restless-Impulsive Subscale Parent Report</measure>
    <time_frame>Baseline through week 3.</time_frame>
    <description>A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners Teacher Global Index</measure>
    <time_frame>Baseline through week 3.</time_frame>
    <description>Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective Reactivity Index - Parent Report</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Modified Overt Aggression Scale - Total Score</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement</measure>
    <time_frame>Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.</time_frame>
    <description>Percentage improved by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>A dimensional measure assessed in cms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Weight in kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Heart rate in beats per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Systolic Blood Pressure measured in mmHG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Diastolic Blood pressure measured in mmHG.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pediatric Anxiety Rating Scale</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Clinician completed dimensional assessment of anxiety symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Children's Depression Rating Scale</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Clinician completed dimensional rating of depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Affective Reactivity Index Child Report</measure>
    <time_frame>Baseline through week 12.</time_frame>
    <description>Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Severe Mood Dysregulation</condition>
  <arm_group>
    <arm_group_label>Adjunctive fluoxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants previously titrated with open-label lisdexamfetamine randomized to adjunctive fluoxetine at end of study week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjunctive placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants previously titrated with open-label lisdexamfetamine randomized to adjunctive placebo at end of study week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Lisdexamfetamine Titration</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants initially titrated with open-label lisdexamfetamine from baseline to end of study week 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lisdexamfetamine</intervention_name>
    <description>Titration and open label treatment from baseline visit for 12 week study.</description>
    <arm_group_label>Adjunctive fluoxetine</arm_group_label>
    <arm_group_label>Adjunctive placebo</arm_group_label>
    <arm_group_label>Open Lisdexamfetamine Titration</arm_group_label>
    <other_name>Vyvanse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Initiated at end of study week 4 and continued to study week 12.</description>
    <arm_group_label>Adjunctive placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluoxetine</intervention_name>
    <description>Initiated at end of study week 4 and continued to study week 12.</description>
    <arm_group_label>Adjunctive fluoxetine</arm_group_label>
    <other_name>Prozac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female participants, ages 7-17 years.&#xD;
&#xD;
          2. Abnormal mood (specifically anger, sadness, and/or irritability), present at least&#xD;
             half of the day most days and of sufficient severity to be noticeable in the child's&#xD;
             environment (e.g. parents, teachers, peers).&#xD;
&#xD;
          3. Hyperarousal, as defined by at least three of the following symptoms: insomnia,&#xD;
             agitation, distractibility, racing thoughts or flight of ideas, pressured speech,&#xD;
             intrusiveness.&#xD;
&#xD;
          4. Compared to his/her peers, the child exhibits markedly increased reactivity to&#xD;
             negative emotional stimuli that is manifest verbally and/or behaviorally. For example,&#xD;
             the child responds to frustration with extended temper tantrums (inappropriate for age&#xD;
             and/or precipitating event), verbal rages, and/or aggression toward people or&#xD;
             property. Such events occur, on average, at least three times a week.&#xD;
&#xD;
          5. Criteria 2, 3, and 4 are currently present and have been present for at least 12&#xD;
             months without any symptom free periods exceeding two months.&#xD;
&#xD;
          6. The onset of symptoms must be prior to age 12 years.&#xD;
&#xD;
          7. The symptoms are severe in at least one setting (e.g. violent outbursts, extreme&#xD;
             verbal abuse, assaultiveness at home, school, or with peers). In addition. There are&#xD;
             at least mild symptoms (distractibility, intrusiveness) in a second setting.&#xD;
&#xD;
          8. Score &gt; 9 on either the Inattentive or Hyperactive/Impulsive subscales of the baseline&#xD;
             ADHD-RS.&#xD;
&#xD;
          9. Score &lt; 12 on the irritability subscale of the Aberrant Behavior Checklist. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. As evidenced in the mania section of the Kiddie-Schedule for Affective Disorders and&#xD;
             Schizophrenia, the individual exhibits any of these cardinal bipolar symptoms in&#xD;
             distinct periods lasting more than 1 day, and therefore meets criteria for bipolar&#xD;
             disorder not otherwise specified (NOS):&#xD;
&#xD;
             i) Elevated or expansive mood. ii) Grandiosity or inflated self esteem. iii) Decreased&#xD;
             need for sleep. iv) Increase in goal-directed activity (this can result in the&#xD;
             excessive involvement in pleasurable activities that have a high potential for painful&#xD;
             consequences).&#xD;
&#xD;
          2. Meets criteria for schizophrenia, schizophreniform, schizoaffective illness, PTSD, or&#xD;
             conduct disorder.&#xD;
&#xD;
          3. T-score greater than/equal to 60 on baseline Social Responsiveness Scale&#xD;
&#xD;
          4. Meets criteria for substance use disorder in the three months prior to baseline.&#xD;
&#xD;
          5. Full scale intelligence &lt; 70.&#xD;
&#xD;
          6. The symptoms are due to the direct physiological effects of drug abuse, or to a&#xD;
             general medical or neurological condition.&#xD;
&#xD;
          7. Currently pregnant or lactating, or sexually active without using an acceptable method&#xD;
             of contraception.&#xD;
&#xD;
          8. Failed an adequate trials (defined as four weeks of consecutive treatment at the&#xD;
             minimally effective dose) or severe ill effects while on therapeutic doses of SSRI&#xD;
             therapy.&#xD;
&#xD;
          9. Hypersensitivity or severe adverse reaction to methylphenidate.&#xD;
&#xD;
         10. History of fainting after exercise, syncope, a young family with sudden cardiac death,&#xD;
             or known structural heart defect.&#xD;
&#xD;
         11. A serious history of adverse reactions (psychosis, severely increased activation&#xD;
             compared to baseline) to methylphenidate or amphetamines.&#xD;
&#xD;
         12. Any chronic medical condition that requires medication that is contraindicated with&#xD;
             SSRI or stimulant therapy, or any serious chronic or unstable medical disorder.&#xD;
&#xD;
         13. Medical contraindication to treatment with SSRI or stimulant therapy. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James J McGough, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Semel Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>December 7, 2017</results_first_submitted>
  <results_first_submitted_qc>January 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2018</results_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>James McGough</investigator_full_name>
    <investigator_title>Professor of Clinical Psychiatry</investigator_title>
  </responsible_party>
  <keyword>severe mood dysregulation</keyword>
  <keyword>irritability</keyword>
  <keyword>lisdexamfetamine</keyword>
  <keyword>fluoxetine</keyword>
  <keyword>newly recognized syndrome</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lisdexamfetamine Dimesylate</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>At completion of open lisdexamfetamine, participants who achieved Clinical Global Impression Severity (CGI-S) SMD score &lt; 4 were deemed sufficiently improved, and not randomized to adjunctive treatment. N=4 participants were sufficiently improved and completed study participation at study week 4, prior to randomization</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fluoxetine</title>
          <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.</description>
        </group>
        <group group_id="P3">
          <title>Open Lisdexamfetamine</title>
          <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing to the end of study week 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open Lisdexamfetamine Titration</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double Blind Adjunctive Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12">Adjunctive fluoxetine treatment was initiated at beginning of Period 2, at study week 4.</participants>
                <participants group_id="P2" count="14">Adjunctive placebo was initiated at beginning of Period 2, at study week 4.</participants>
                <participants group_id="P3" count="0">No one remained on lisdexamfetamine alone in Period 2.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>See Participant Flow descriptions.</population>
      <group_list>
        <group group_id="B1">
          <title>Open Lisdexamfetamine</title>
          <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 3.</description>
        </group>
        <group group_id="B2">
          <title>Fluoxetine</title>
          <description>Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive fluoxetine therapy from week 4 through week 12.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Randomized participants who competed open-label lisdexamfetamine titration from baseline through week 3, who continued to meet eligibility criteria, and then proceeded to adjunctive placebo from week 4 through week 12.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Columns for baseline measures are not additive, as fluoxetine and placebo groups are a subset of the original 34 participants entered into phase 1.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.24" spread="2.58"/>
                    <measurement group_id="B2" value="9.97" spread="2.30"/>
                    <measurement group_id="B3" value="10.22" spread="2.74"/>
                    <measurement group_id="B4" value="NA" spread="NA">Columns are not additive, as described above.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wechsler Abbreviated Scale of Intelligence</title>
          <description>Standard IQ measure for youth, frequently used in clinical studies, based on an administered test, with mean population score = 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103.16" spread="14.30"/>
                    <measurement group_id="B2" value="105.58" spread="15.56"/>
                    <measurement group_id="B3" value="101.69" spread="14.34"/>
                    <measurement group_id="B4" value="NA" spread="NA">Columns not additive as described above.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Global Impression SMD Severity</title>
          <description>A dimensional NIH measures used to quantify severity of severe mood dysregulation. Minimum score = 1. Maximum score = 7. Higher scores mean greater impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.82" spread=".52"/>
                    <measurement group_id="B2" value="4.75" spread=".46"/>
                    <measurement group_id="B3" value="4.83" spread=".72"/>
                    <measurement group_id="B4" value="NA" spread="NA">Columns not additive as described above.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Affective Reactivity Index Parent Report</title>
          <description>A parent completed dimensional measure of irritability on a scale of 0 to 14, with 14 being most severe.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.91" spread="2.47"/>
                    <measurement group_id="B2" value="10.00" spread="1.95"/>
                    <measurement group_id="B3" value="8.57" spread="2.17"/>
                    <measurement group_id="B4" value="NA" spread="NA">Columns not additive as described above.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Global Impression-Severity-Severe Mood Dysregulation</title>
        <description>A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine starting at baseline (week 0) and continuing through study week.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression-Severity-Severe Mood Dysregulation</title>
          <description>A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.</description>
          <population>Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.91" spread=".53"/>
                    <measurement group_id="O2" value="3.62" spread=".48"/>
                    <measurement group_id="O3" value="4.30" spread=".32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.42" spread=".34"/>
                    <measurement group_id="O2" value="4.57" spread=".31"/>
                    <measurement group_id="O3" value="4.31" spread=".19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread=".36"/>
                    <measurement group_id="O2" value="3.51" spread=".32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread=".34"/>
                    <measurement group_id="O2" value="3.90" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread=".37"/>
                    <measurement group_id="O2" value="3.59" spread=".34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.42" spread=".39"/>
                    <measurement group_id="O2" value="3.37" spread=".34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.45" spread=".42"/>
                    <measurement group_id="O2" value="3.11" spread=".35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" spread=".38"/>
                    <measurement group_id="O2" value="3.30" spread=".36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.58</p_value>
            <p_value_desc>Group: F=.31, df=1/140</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.85</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=.03, df=1/140</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.26</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=1.28, df=1/140</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ADHD-IV Rating Scale</title>
        <description>A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at end of study week 4 6 continuing through week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at end of study week 4 and continuing through week.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.</description>
          </group>
        </group_list>
        <measure>
          <title>ADHD-IV Rating Scale</title>
          <description>A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.</description>
          <population>Participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.50" spread="1.97"/>
                    <measurement group_id="O2" value="34.31" spread="1.87"/>
                    <measurement group_id="O3" value="34.20" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.92" spread="1.97"/>
                    <measurement group_id="O2" value="18.64" spread="1.82"/>
                    <measurement group_id="O3" value="16.59" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.29" spread="2.10"/>
                    <measurement group_id="O2" value="11.93" spread="1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.97</p_value>
            <p_value_desc>Group: F=0.00, df=1/44</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0002</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=136.22, df=1/44</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=64.90, df=1/44</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conners Parent Global Index</title>
        <description>Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.</description>
        <time_frame>Baseline through week 3.</time_frame>
        <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing tp week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 and continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Conners Parent Global Index</title>
          <description>Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.</description>
          <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="15.91" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="9.54" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="10.60" spread=".85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8.60" spread=".87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Time: F=41.85, df=1/89, p&lt;.0001.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear regression of outcome change over time within single group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conners Global Index Emotional Lability Subscale - Parent Report</title>
        <description>A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.</description>
        <time_frame>Baseline to week 3.</time_frame>
        <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Conners Global Index Emotional Lability Subscale - Parent Report</title>
          <description>A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.</description>
          <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8.81" spread=".52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="5.90" spread=".52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="6.33" spread=".53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="5.45" spread=".55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Time: F=26.65, df=1/92, p &lt;.0001.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear regression of outcome change over time within single group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conners Global Index Restless-Impulsive Subscale Parent Report</title>
        <description>A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.</description>
        <time_frame>Baseline through week 3.</time_frame>
        <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 though week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine at study visits 2-6.</description>
          </group>
        </group_list>
        <measure>
          <title>Conners Global Index Restless-Impulsive Subscale Parent Report</title>
          <description>A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.</description>
          <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="15.91" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="9.55" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="10.60" spread=".85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8.60" spread=".87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Time: F=40.35, df=1/89, p &lt; .0001.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear regression of outcome change over time within single group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conners Teacher Global Index</title>
        <description>Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.</description>
        <time_frame>Baseline through week 3.</time_frame>
        <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Conners Teacher Global Index</title>
          <description>Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.</description>
          <population>Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="18.13" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="13.21" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="10.18" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8.31" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Time: F=26.36, df=1/29, p &lt;.0001.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Linear regression of outcome change over time within single group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Affective Reactivity Index - Parent Report</title>
        <description>A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Affective Reactivity Index - Parent Report</title>
          <description>A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.00" spread=".96"/>
                    <measurement group_id="O2" value="8.57" spread=".88"/>
                    <measurement group_id="O3" value="9.29" spread=".92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.58" spread=".96"/>
                    <measurement group_id="O2" value="7.71" spread=".88"/>
                    <measurement group_id="O3" value="6.87" spread=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" spread=".96"/>
                    <measurement group_id="O2" value="6.21" spread=".88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.42" spread=".96"/>
                    <measurement group_id="O2" value="5.32" spread=".90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.69" spread="1.00"/>
                    <measurement group_id="O2" value="6.49" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.49" spread="1.00"/>
                    <measurement group_id="O2" value="5.62" spread=".90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.74" spread="1.07"/>
                    <measurement group_id="O2" value="4.89" spread=".97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.39" spread="1.00"/>
                    <measurement group_id="O2" value="5.30" spread=".94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.44</p_value>
            <p_value_desc>Group: F=.60, df=1/157</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=22.39, df=1/157</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.04</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=4.40, df=1/157</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Revised Modified Overt Aggression Scale - Total Score</title>
        <description>A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Revised Modified Overt Aggression Scale - Total Score</title>
          <description>A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.23" spread="4.44"/>
                    <measurement group_id="O2" value="33.68" spread="4.08"/>
                    <measurement group_id="O3" value="26.03" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.44" spread="4.30"/>
                    <measurement group_id="O2" value="25.35" spread="3.98"/>
                    <measurement group_id="O3" value="17.93" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.72" spread="4.31"/>
                    <measurement group_id="O2" value="20.60" spread="4.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.00" spread="4.20"/>
                    <measurement group_id="O2" value="20.55" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.19" spread="4.45"/>
                    <measurement group_id="O2" value="21.89" spread="4.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.09" spread="4.45"/>
                    <measurement group_id="O2" value="21.33" spread="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.61" spread="4.60"/>
                    <measurement group_id="O2" value="17.68" spread="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.29" spread="4.45"/>
                    <measurement group_id="O2" value="18.34" spread="4.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.05</p_value>
            <p_value_desc>Group: F=3.81, df=1/145</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
            <other_analysis_desc>No significant group*time interactions. Group trend likely due to baseline differences.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.0001</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Tie: F=15.28, df=1/145</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=5.42, df=1/145</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression - Improvement</title>
        <description>Percentage improved by treatment group</description>
        <time_frame>Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at study week 4 and continuing to study week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through study week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression - Improvement</title>
          <description>Percentage improved by treatment group</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.76</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi Square = .10, df=1, p=.76</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height</title>
        <description>A dimensional measure assessed in cms.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Height</title>
          <description>A dimensional measure assessed in cms.</description>
          <population>Participants discontinued as trial progressed.</population>
          <units>cm.</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.25" spread="3.82"/>
                    <measurement group_id="O2" value="144.63" spread="3.53"/>
                    <measurement group_id="O3" value="142.37" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.05" spread="3.81"/>
                    <measurement group_id="O2" value="144.76" spread="3.53"/>
                    <measurement group_id="O3" value="142.35" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.95" spread="3.82"/>
                    <measurement group_id="O2" value="144.81" spread="3.53"/>
                    <measurement group_id="O3" value="142.43" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.26" spread="3.82"/>
                    <measurement group_id="O2" value="144.88" spread="3.53"/>
                    <measurement group_id="O3" value="142.59" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.56" spread="3.82"/>
                    <measurement group_id="O2" value="144.54" spread="3.53"/>
                    <measurement group_id="O3" value="142.59" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.11" spread="3.82"/>
                    <measurement group_id="O2" value="144.82" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.21" spread="3.82"/>
                    <measurement group_id="O2" value="145.44" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.55" spread="3.82"/>
                    <measurement group_id="O2" value="145.14" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.81" spread="3.82"/>
                    <measurement group_id="O2" value="144.98" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.83" spread="3.82"/>
                    <measurement group_id="O2" value="145.30" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.98" spread="3.82"/>
                    <measurement group_id="O2" value="145.60" spread="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.38</p_value>
            <p_value_desc>Group: F=.78, df=1/220</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.42</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=.66, df=1/220</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.13</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=.66, df=1/220</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Weight in kg.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Weight in kg.</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>kg.</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.96" spread="5.26"/>
                    <measurement group_id="O2" value="47.26" spread="4.87"/>
                    <measurement group_id="O3" value="42.59" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.29" spread="5.26"/>
                    <measurement group_id="O2" value="46.39" spread="4.87"/>
                    <measurement group_id="O3" value="41.83" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.96" spread="5.26"/>
                    <measurement group_id="O2" value="45.56" spread="4.87"/>
                    <measurement group_id="O3" value="41.29" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.55" spread="5.26"/>
                    <measurement group_id="O2" value="45.06" spread="4.87"/>
                    <measurement group_id="O3" value="40.73" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.20" spread="5.26"/>
                    <measurement group_id="O2" value="45.22" spread="4.87"/>
                    <measurement group_id="O3" value="40.67" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.08" spread="5.26"/>
                    <measurement group_id="O2" value="44.80" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.73" spread="5.26"/>
                    <measurement group_id="O2" value="44.34" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.30" spread="5.26"/>
                    <measurement group_id="O2" value="44.72" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.08" spread="5.26"/>
                    <measurement group_id="O2" value="44.08" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.61" spread="5.26"/>
                    <measurement group_id="O2" value="44.16" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.73" spread="5.26"/>
                    <measurement group_id="O2" value="43.05" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.21</p_value>
            <p_value_desc>Group: F=1.56, df=1/222</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=63.11, df=1/222</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.0004</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=12.86, df=1/222</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulse</title>
        <description>Heart rate in beats per minute.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse</title>
          <description>Heart rate in beats per minute.</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>beats per minute.</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.28" spread="3.26"/>
                    <measurement group_id="O2" value="84.64" spread="3.22"/>
                    <measurement group_id="O3" value="80.84" spread="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.08" spread="3.16"/>
                    <measurement group_id="O2" value="85.21" spread="2.91"/>
                    <measurement group_id="O3" value="88.15" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.25" spread="3.15"/>
                    <measurement group_id="O2" value="81.64" spread="2.91"/>
                    <measurement group_id="O3" value="84.33" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.32" spread="3.26"/>
                    <measurement group_id="O2" value="85.79" spread="3.01"/>
                    <measurement group_id="O3" value="90.71" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.08" spread="3.15"/>
                    <measurement group_id="O2" value="83.21" spread="2.91"/>
                    <measurement group_id="O3" value="88.45" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.16" spread="3.26"/>
                    <measurement group_id="O2" value="83.00" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.33" spread="3.15"/>
                    <measurement group_id="O2" value="90.55" spread="3.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.94" spread="3.55"/>
                    <measurement group_id="O2" value="90.00" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.17" spread="3.40"/>
                    <measurement group_id="O2" value="85.10" spread="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.83" spread="3.55"/>
                    <measurement group_id="O2" value="82.90" spread="3.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.75" spread="3.55"/>
                    <measurement group_id="O2" value="90.62" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <p_value_desc>Group: F=5.42, df=1/223</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.18</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=1.77, df=1/223</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.49</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=.47, df=1/223</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure</title>
        <description>Systolic Blood Pressure measured in mmHG</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Systolic Blood Pressure measured in mmHG</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>mm Hg.</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.85" spread="4.01"/>
                    <measurement group_id="O2" value="106.68" spread="3.92"/>
                    <measurement group_id="O3" value="107.40" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.42" spread="3.89"/>
                    <measurement group_id="O2" value="111.71" spread="3.60"/>
                    <measurement group_id="O3" value="106.03" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.83" spread="3.89"/>
                    <measurement group_id="O2" value="110.36" spread="3.60"/>
                    <measurement group_id="O3" value="107.48" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.20" spread="4.01"/>
                    <measurement group_id="O2" value="109.89" spread="3.70"/>
                    <measurement group_id="O3" value="110.73" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.00" spread="3.89"/>
                    <measurement group_id="O2" value="110.07" spread="3.60"/>
                    <measurement group_id="O3" value="111.77" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.57" spread="4.01"/>
                    <measurement group_id="O2" value="104.20" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.58" spread="3.89"/>
                    <measurement group_id="O2" value="108.98" spread="3.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.04" spread="4.31"/>
                    <measurement group_id="O2" value="112.80" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.20" spread="4.31"/>
                    <measurement group_id="O2" value="110.94" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.25" spread="4.31"/>
                    <measurement group_id="O2" value="105.67" spread="4.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.15" spread="4.31"/>
                    <measurement group_id="O2" value="113.90" spread="3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.90</p_value>
            <p_value_desc>Group: F=.02, df=1/223</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.21</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=1.60, df=1/223</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.73</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=.12, df=1/223</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure</title>
        <description>Diastolic Blood pressure measured in mmHG.</description>
        <time_frame>Baseline through week 12.</time_frame>
        <population>Some participants discontinued as trial progressed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluoxetine</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 continuing to week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at week 4 continuing through week 12.</description>
          </group>
          <group group_id="O3">
            <title>Open Lisdexamfetamine</title>
            <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine beginning at baseline (week 0) and continuing through study week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <description>Diastolic Blood pressure measured in mmHG.</description>
          <population>Some participants discontinued as trial progressed.</population>
          <units>mm Hg.</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.86" spread="2.36"/>
                    <measurement group_id="O2" value="66.40" spread="2.34"/>
                    <measurement group_id="O3" value="67.39" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.33" spread="2.27"/>
                    <measurement group_id="O2" value="69.50" spread="2.10"/>
                    <measurement group_id="O3" value="69.15" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.00" spread="2.27"/>
                    <measurement group_id="O2" value="66.79" spread="2.10"/>
                    <measurement group_id="O3" value="66.63" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.74" spread="2.36"/>
                    <measurement group_id="O2" value="62.82" spread="2.18"/>
                    <measurement group_id="O3" value="67.21" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.17" spread="2.27"/>
                    <measurement group_id="O2" value="66.21" spread="2.10"/>
                    <measurement group_id="O3" value="69.31" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.17" spread="2.36"/>
                    <measurement group_id="O2" value="65.17" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.58" spread="2.27"/>
                    <measurement group_id="O2" value="70.61" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.14" spread="2.58"/>
                    <measurement group_id="O2" value="70.64" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.06" spread="2.46"/>
                    <measurement group_id="O2" value="68.40" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.81" spread="2.58"/>
                    <measurement group_id="O2" value="67.06" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.11" spread="2.58"/>
                    <measurement group_id="O2" value="70.05" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.15</p_value>
            <p_value_desc>Group: F=2.05, df=1/223</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.59</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time: F=.29, df=1/223</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.14</p_value>
            <p_value_desc>Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Time2: F=2.15, df=1/223</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pediatric Anxiety Rating Scale</title>
        <description>Clinician completed dimensional assessment of anxiety symptoms.</description>
        <time_frame>Baseline through week 12.</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Children's Depression Rating Scale</title>
        <description>Clinician completed dimensional rating of depressive symptoms.</description>
        <time_frame>Baseline through week 12.</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Affective Reactivity Index Child Report</title>
        <description>Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.</description>
        <time_frame>Baseline through week 12.</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through study week 12.</time_frame>
      <desc>Adverse events were collected via structured ratings, including the Columbia Suicide Severity Rating Scale and the Side Effects Rating Scale.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fluoxetine</title>
          <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive fluoxetine at week 4 and continuing though week 12.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>All participants initially enrolled in open lisdexamfetamine treatment, followed by randomization to adjunctive placebo at study week 4 and continuing through week 12.</description>
        </group>
        <group group_id="E3">
          <title>Open Lisdexamfetamine</title>
          <description>All eligible participants initially titrated to optimal dose open lisdexamfetamine from baseline through week 4.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart skips beats</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Racing heart</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach pain/ache</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea/vomiting</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling drowsy/sleep</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Restless/uncomfortable urge to move</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="24" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E3" events="51" subjects_affected="21" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Excessive sweating</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Tremor/shakiness</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Tics</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Bites fingernails</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Wish to be dead</sub_title>
                <description>Endorsed on Columbia Suicide Severity Rating Scale</description>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Suicidal ideation without intent</sub_title>
                <description>Endorsed on Columbia Suicide Severity Rating Scale</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Trouble sleeping</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" events="15" subjects_affected="9" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sleeplessness</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="9" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nightmares</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Euphoria</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Talks less with others</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Prone to crying</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Frequent urination</sub_title>
                <description>Clinically significant symptom with post baseline onset based on parent completed Physical Symptoms Checklist.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was designed as an initial feasibility and proof of concept trial. Initial power analysis suggested need to randomize N=50 participants. Recruitment was much more difficult than expected, leading to small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>James J. McGough, M.D.</name_or_title>
      <organization>University of California, Los Angeles</organization>
      <phone>310-794-7841</phone>
      <email>jmcgough@mednet.ucla.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714310
org study id: U01MH093582
secondary id: U01MH093582
nct id: NCT01714310
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This project will characterize children and adolescents with severe mood dysregulation (SMD)
      and conduct a pilot study of combination pharmacotherapy as a basis for future intervention
      trials.

      Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine
      (LDX) to optimal dose, followed by double-blind randomization to fluoxetine (N=25) or placebo
      (N=25) in combination with optimized LDX for an additional 8 weeks. Participants will be
      monitored for clinical response and adverse events.

      Specific aims are:

      #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive
      functioning, and a potential "bio-signature" derived from electroencephalography (EEG).

      Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison
      to non-SMD individuals in our pre-existing database on patterns of a) psychiatric
      comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2)
      that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with
      SMD.

      #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant
      followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI)
      therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability
      of the proposed combination treatment as a basis for future clinical investigations.

      Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global
      Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident
      after open-label LDX titration; 2) that participants randomized to fluoxetine will
      demonstrate additional significant improvement in CGI-I-SMD scores and other secondary
      measures in comparison to participants randomized to placebo; 3) that combination LDX and
      SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with
      treatment.
Background

      The increased frequency of diagnosed pediatric bipolar disorder has emerged as one of the
      greatest controversies in child and adolescent psychiatry. Beginning with reports that 20% of
      prepubertal of children with Attention-Deficit/Hyperactivity Disorder (ADHD) met criteria for
      juvenile mania, a view arose that bipolar children were more irritable than euphoric and more
      chronic than episodic, compared with the typical adult. Concurrently, there was a 4 to 6-fold
      increase in inpatient discharges and 40-fold increase in office-based visits for pediatric
      bipolar disorder, although many of these failed to meet formal Diagnostic and Statistical
      Manual (DSM) criteria. Concerns have been raised that any child with impulsive, volatile
      behavior is apt to be diagnosed as bipolar.

      Some attempted to inform valid symptomatic boundaries by proposing a differentiation of
      narrow versus broad pediatric bipolar phenotypes. The narrow phenotype was defined by strict
      DSM criteria for mania or hypomania, including discrete episodes of grandiosity and euphoria.
      In contrast, the broad phenotype, also referred to as severe mood dysregulation (SMD), was
      defined by chronic, non-episodic illness lacking hallmark symptoms of grandiosity and
      euphoria, but typified by severe irritability and hyperarousal. Work at the National
      Institute of Mental Health (NIMH) demonstrated that patterns of adolescent irritability are
      stable and distinct, with episodic irritability leading to mania and simple phobia, and
      chronic irritability leading to diagnosed depression and ADHD. On structured assessment,
      children with SMD were highly comorbid for major depression (20%), anxiety (64%),
      oppositional defiant disorder (83%), and ADHD (87%). Others also found increased rates of
      ADHD and anxiety. In addition, the broad and narrow phenotypes could be differentiated
      according to electroencephalography (EEG) measures. SMD youth have impaired face emotion
      recognition deficits correlated with dysfunctional family relationships and were less
      influenced by emotional distracters during tasks of attention. A recent study revealed
      patterns of amygdala hypoactivation similar to depression, further supporting links between
      chronic irritability and subsequent depressive episodes.

      In response to the perceived over-diagnosis of pediatric DSM bipolar disorder, acknowledgment
      that the "classic" adult bipolar phenotype does occur in prepubertal youth, and increased
      recognition that SMD is a distinct behavioral and/or biological syndrome, the DSM-5 Child
      Disorders Workgroup proposed a new diagnostic category named temper dysregulation disorder
      with dysphoria (TDD). Criteria for TDD were largely based on SMD, however, the requirement
      for hyperarousal was removed and minor changes were made in age of onset and exclusion
      criteria. Unlike SMD, TDD lacks any demonstrated scientific basis or history of prior
      research. As such, it seems prudent at this time to continue research on the
      better-established SMD category with an expectation that any information derived will have
      ready applicability as work on TDD progresses.

      One preliminary report suggests that SMD has a lifetime prevalence of 3.3% among those ages
      9-19. Recent longitudinal studies further indicate that children with SMD have increased
      rates of adult mood and anxiety disorders, substance abuse, suicidality, and poorer overall
      functioning. Given this significant morbidity, it is essential that the investigators
      increase understanding of children with chronic irritability and affective instability.
      Impulsive aggression in childhood has been identified as a significant public health concern
      that cuts across currently defined diagnostic categories. These youth demonstrate increased
      difficulties with school adjustment, peer interactions, cognitive deficits, problem-solving,
      and physical abuse - a developmental trajectory predictive of significant adult dysfunction.

      Current community practice emphasizes use of second-generation antipsychotic agents for
      children with impulsive aggression. While risperidone has proven effective for irritability
      associated with pervasive developmental disorders [25,26] and second-generation
      antipsychotics have been effective in pediatric bipolar disorder, these agents are associated
      with significant weight gain and other metabolic effects. Use of these medications is
      associated with decreased utilization of psychosocial interventions. Given the relationship
      of SMD with ADHD, anxiety, and unipolar depression, investigations of drugs from other
      classes with targeted effects and better side effect profiles, such as mood stabilizers,
      antidepressants, and stimulants, are certainly warranted. In fact, the DSM-5 Workgroup has
      specifically called for clinical trials stating it is "critically important" to assess
      whether stimulants and SSRIs should be first line treatments in SMD-affected youth. The only
      published medication trial in SMD youth is a double-blind placebo controlled study of lithium
      conducted by the intramural group at NIMH, which failed to demonstrate effects. Other
      informative investigations include small positive studies of methylphenidate versus placebo
      for ADHD plus oppositional defiant disorder and aggression, open-label stimulant followed by
      adjuvant divalproex vs. placebo for ADHD and aggression, and stimulant augmentation with
      double-blind risperidone versus placebo in ADHD with treatment resistant aggression. These
      studies are notably heterogeneous in design and choice of outcome measures. No clear
      predictors of response have been reported.

      Most existing SMD research has been conducted by a single intramural group at NIMH. It is
      imperative that investigations of SMD be expanded to other research groups to ensure that
      results generalize to broad clinical settings. Additional research is required to delineate
      clinical phenomenology that will inform subsequent efforts at diagnostic classification.
      Further work is also necessary to establish the appropriate foundation for future clinical
      interventions research. This should include pilot studies of various medication classes that
      might prove useful in management of SMD, as well as examination of various outcome measures
      that are likely to be useful in both medication and psychosocial intervention trials.

      Overview

      The study will include comprehensive phenotyping of 65 patients meeting criteria for SMD,
      including assessment of comorbid psychopathology, language disorder, neurocognition, and EEG.
      Potential endophenotypes and diagnostic boundaries will be assessed in relation to our large
      existing database of children and adolescents with internalizing and externalizing disorders,
      as well as non-clinical controls. Eligible participants with SMD will proceed to a pilot
      study of sequential pharmacotherapy with an initial 4-week titration of open label
      lisdexamfetamine (LDX) followed by 8 weeks adjunctive therapy with randomized fluoxetine or
      placebo. Statistical analyses will address diagnostic boundaries of SMD compared with other
      disorders and emphasize initial determinations of the potential efficacy and tolerability of
      stimulant and SSRI treatments for SMD. There will be an added emphasis on effect size
      estimates and determination of optimal outcome measures in anticipation of future large-scale
      studies.

      Project Visits and Procedures

      Following baseline visit (week 0), eligible participants will undergo undergo open-label
      stepwise titration with one week each of low, medium, and high dose LDX during study weeks 1,
      2, and 3. The study physician may modify titration due to emergent side effects following
      routine practice standards.

      At the end of study week 3, the clinician will determine "optimal" stimulant dose based on
      review of parent and teacher-completed Conners Global Index scales and all available adverse
      event and side effects data, using procedures similar to those used in other studies.
      Participants will remain on this optimal stimulant dose for the remainder of the study,
      unless side effects necessitate some downward dose adjustment.

      At study week 4, participants who fail to achieve CGI-I-SMD score < 4 will be randomized to
      double blind adjunctive treatment with either fluoxetine or placebo.

      A forced dose, stepwise, upward titration of one week each of 5, 10, and 20 mg
      fluoxetine/placebo will occur at during week 5, 6, and 7. The treating physician may modify
      this titration schedule in response to emergent side effect following routine practice
      standards. Participants will remain on their week 7 doses of fluoxetine/placebo until the
      study's final visit, unless side effects necessitate some downward titration.

      Side effects, adverse events, and medication compliance will be assessed at each visit. Major
      outcome assessments will occur at baseline (week 0) , end of week 4, and end of week 12.

      Arrangements will be made to transfer participants to standard clinical care following week
      12.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Initial arm for open-label titration of lisdexamfetamine followed by randomization of participants who retain eligibility to double blind adjunctive fluoxetine or placebo.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical Global Impression-Severity-Severe Mood Dysregulation
time frame: Baseline through week 12.
description: A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.
measure: ADHD-IV Rating Scale
time frame: Baseline through week 12.
description: A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
measure: Conners Parent Global Index
time frame: Baseline through week 3.
description: Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.
measure: Conners Global Index Emotional Lability Subscale - Parent Report
time frame: Baseline to week 3.
description: A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.
measure: Conners Global Index Restless-Impulsive Subscale Parent Report
time frame: Baseline through week 3.
description: A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.
measure: Conners Teacher Global Index
time frame: Baseline through week 3.
description: Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.
measure: Affective Reactivity Index - Parent Report
time frame: Baseline through week 12.
description: A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
measure: Revised Modified Overt Aggression Scale - Total Score
time frame: Baseline through week 12.
description: A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.
measure: Clinical Global Impression - Improvement
time frame: Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.
description: Percentage improved by treatment group
measure: Height
time frame: Baseline through week 12.
description: A dimensional measure assessed in cms.
measure: Weight
time frame: Baseline through week 12.
description: Weight in kg.
measure: Pulse
time frame: Baseline through week 12.
description: Heart rate in beats per minute.
measure: Systolic Blood Pressure
time frame: Baseline through week 12.
description: Systolic Blood Pressure measured in mmHG
measure: Diastolic Blood Pressure
time frame: Baseline through week 12.
description: Diastolic Blood pressure measured in mmHG.
measure: Pediatric Anxiety Rating Scale
time frame: Baseline through week 12.
description: Clinician completed dimensional assessment of anxiety symptoms.
measure: Children's Depression Rating Scale
time frame: Baseline through week 12.
description: Clinician completed dimensional rating of depressive symptoms.
measure: Affective Reactivity Index Child Report
time frame: Baseline through week 12.
description: Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.
arm group label: Adjunctive fluoxetine
arm group type: Experimental
description: Participants previously titrated with open-label lisdexamfetamine randomized to adjunctive fluoxetine at end of study week 4.
arm group label: Adjunctive placebo
arm group type: Placebo Comparator
description: Participants previously titrated with open-label lisdexamfetamine randomized to adjunctive placebo at end of study week 4.
arm group label: Open Lisdexamfetamine Titration
arm group type: Other
description: All participants initially titrated with open-label lisdexamfetamine from baseline to end of study week 4.
intervention type: Drug
intervention name: lisdexamfetamine
description: Titration and open label treatment from baseline visit for 12 week study.
arm group label: Adjunctive fluoxetine
arm group label: Adjunctive placebo
arm group label: Open Lisdexamfetamine Titration
other name: Vyvanse
intervention type: Drug
intervention name: Placebo
description: Initiated at end of study week 4 and continued to study week 12.
arm group label: Adjunctive placebo
intervention type: Drug
intervention name: fluoxetine
description: Initiated at end of study week 4 and continued to study week 12.
arm group label: Adjunctive fluoxetine
other name: Prozac
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: James J McGough, M.D.
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: James McGough
investigator title: Professor of Clinical Psychiatry
mesh term: Lisdexamfetamine Dimesylate
mesh term: Fluoxetine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was designed as an initial feasibility and proof of concept trial. Initial power analysis suggested need to randomize N=50 participants. Recruitment was much more difficult than expected, leading to small sample size.
point of contact: 