<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/NCT03250013</url>
  </required_header>
  <id_info>
    <org_study_id>LMA trial Goteborg</org_study_id>
    <nct_id>NCT03250013</nct_id>
  </id_info>
  <brief_title>Long-term Effects of Medication for ADHD</brief_title>
  <acronym>LMA</acronym>
  <official_title>Long-term Effects of Medication for Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents on Cognition, Everyday Function and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17&#xD;
      years, who receive medication for ADHD of any subtype (presentation). Long-term results are&#xD;
      evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales;&#xD;
      WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional&#xD;
      Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition&#xD;
      Scale; CHIP-CE) during 24 months of ADHD treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single-centre open-label prospective study, including 127 subjects over a period of 2 years.&#xD;
      Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and&#xD;
      followed during 24 months of ADHD treatment.&#xD;
&#xD;
      Screening assessments include medical, neurodevelopmental and psychiatric history, clinical&#xD;
      evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according&#xD;
      to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global&#xD;
      functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and&#xD;
      Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities&#xD;
      (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical&#xD;
      interview), intellectual ability (by the WISC test), and general level of functioning (by the&#xD;
      Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the&#xD;
      screening visit to ascertain a current evaluation and definition of these parameters.&#xD;
&#xD;
      At baseline, a Qb-test and an assessment of symptom severity and global functional impairment&#xD;
      will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by&#xD;
      parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report&#xD;
      will be collected by interview with open-ended questions. Assignment to treatment will be&#xD;
      individualized according to clinical picture and patient preference.&#xD;
&#xD;
      At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be&#xD;
      performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement&#xD;
      (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse&#xD;
      event report. Compliance assessment through pill count. Assessment of comorbidity status&#xD;
      according to DSM-IV and DSM 5 checklist/interview.&#xD;
&#xD;
      A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of&#xD;
      life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.&#xD;
&#xD;
      Duration of study treatment per subject is 24 months. Medication dosage is 1-3 doses daily as&#xD;
      needed to optimize symptom control. Medications (methylphenidate, amphetamine, atomoxetine)&#xD;
      will be provided by the pharmacy according to routines in standard clinical treatment.&#xD;
&#xD;
      For cluster analysis of Qb-test results, retrospective data from at least 50 patients&#xD;
      previously diagnosed at our clinic will be added to the data from the subjects participating&#xD;
      in the prospective study, to increase sample size to ascertain sufficient power for subgroup&#xD;
      (cluster) analysis.&#xD;
&#xD;
      Safety evaluations Adverse event (AE) reports will be collected at all visits through&#xD;
      open-ended questions. Vital signs (height, weight, blood pressure, pulse) will be assessed at&#xD;
      all visits. AE severity should be graded: Mild, Moderate or Severe, and all AEs must be&#xD;
      followed until an outcome is known, ensuring the subject's safety. All AEs will be recorded&#xD;
      in the subject's medical records and in the Clinical Report Form (CRF), and also reported to&#xD;
      the Medical Products Agency according to local regulations.&#xD;
&#xD;
      Study population Approximately 100 subjects from our centre will be enrolled in the&#xD;
      prospective study.&#xD;
&#xD;
      Retrospective data for the cluster analysis will be collected from at least 50 patients&#xD;
      previously diagnosed at our centre.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">January 30, 2022</completion_date>
  <primary_completion_date type="Actual">January 30, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in CGI - (S and I)</measure>
    <time_frame>0, 1, 2, 3, 6, 12, 18 and 24 months</time_frame>
    <description>Investigator-rated clinical global impression scale - severity and improvement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADHD Rating Scale</measure>
    <time_frame>0, 1, 2, 3, 6, 12, 18 and 24 months</time_frame>
    <description>Clinician-rated ADHD symptom scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qb-test</measure>
    <time_frame>0, 1 and 12 months</time_frame>
    <description>Computerized ADHD-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WISC-IV</measure>
    <time_frame>0 and 12 months</time_frame>
    <description>Wechsler Intelligence Scale for Children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vineland scale</measure>
    <time_frame>0 and 12 months</time_frame>
    <description>Vineland parent interview of functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weiss Functional Impairment Scale (WFIRS)</measure>
    <time_frame>0, 12 and 24 months</time_frame>
    <description>Parent-rated function scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health and Illness Profile - Child Edition (CHIP-CE)</measure>
    <time_frame>0, 12 and 24 months</time_frame>
    <description>Parent-rated quality of life scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Children and adolescents with ADHD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children and adolescents medicating for ADHD of any subtype (presentation) with comorbidities</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADHD medications</intervention_name>
    <arm_group_label>Children and adolescents with ADHD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children 6-17 years of age&#xD;
&#xD;
          2. Clinical diagnosis ADHD of any subtype and DSM 5 presentation&#xD;
&#xD;
          3. Intellectual ability in the normal range, according to Wechsler tests and clinical&#xD;
             judgment&#xD;
&#xD;
          4. Subjects treated with ADHD medication will have a wash-out period prior to Qb-test at&#xD;
             baseline, of 1 week for methylphenidate or amphetamine, 2 weeks for atomoxetine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physical or psychological limitation making Qb-test unsuitable.&#xD;
&#xD;
          2. Cardiovascular disease, seizures or other unstable medical conditions that might&#xD;
             increase the risk for the subject.&#xD;
&#xD;
          3. Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid&#xD;
             or medical conditions that in the investigator's opinion would make study&#xD;
             participation unsuitable.&#xD;
&#xD;
          4. Concomitant medications (allowed at investigator's discretion), must be recorded in&#xD;
             the subject's medical records and the CRF.&#xD;
&#xD;
          5. Substance use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mats Johnson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Child Neuropsychiatry Unit, Sahlgrenska University Hospital, Gothenburg, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child Neuropsychiatry Unit, Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>41118</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 26, 2022</last_update_submitted>
  <last_update_submitted_qc>February 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03250013
org study id: LMA trial Goteborg
nct id: NCT03250013
lead sponsor: 
has dmc: No
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17
      years, who receive medication for ADHD of any subtype (presentation). Long-term results are
      evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales;
      WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional
      Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition
      Scale; CHIP-CE) during 24 months of ADHD treatment.
Single-centre open-label prospective study, including 127 subjects over a period of 2 years.
      Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and
      followed during 24 months of ADHD treatment.

      Screening assessments include medical, neurodevelopmental and psychiatric history, clinical
      evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according
      to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global
      functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and
      Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities
      (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical
      interview), intellectual ability (by the WISC test), and general level of functioning (by the
      Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the
      screening visit to ascertain a current evaluation and definition of these parameters.

      At baseline, a Qb-test and an assessment of symptom severity and global functional impairment
      will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by
      parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report
      will be collected by interview with open-ended questions. Assignment to treatment will be
      individualized according to clinical picture and patient preference.

      At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be
      performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement
      (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse
      event report. Compliance assessment through pill count. Assessment of comorbidity status
      according to DSM-IV and DSM 5 checklist/interview.

      A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of
      life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.

      Duration of study treatment per subject is 24 months. Medication dosage is 1-3 doses daily as
      needed to optimize symptom control. Medications (methylphenidate, amphetamine, atomoxetine)
      will be provided by the pharmacy according to routines in standard clinical treatment.

      For cluster analysis of Qb-test results, retrospective data from at least 50 patients
      previously diagnosed at our clinic will be added to the data from the subjects participating
      in the prospective study, to increase sample size to ascertain sufficient power for subgroup
      (cluster) analysis.

      Safety evaluations Adverse event (AE) reports will be collected at all visits through
      open-ended questions. Vital signs (height, weight, blood pressure, pulse) will be assessed at
      all visits. AE severity should be graded: Mild, Moderate or Severe, and all AEs must be
      followed until an outcome is known, ensuring the subject's safety. All AEs will be recorded
      in the subject's medical records and in the Clinical Report Form (CRF), and also reported to
      the Medical Products Agency according to local regulations.

      Study population Approximately 100 subjects from our centre will be enrolled in the
      prospective study.

      Retrospective data for the cluster analysis will be collected from at least 50 patients
      previously diagnosed at our centre.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in CGI - (S and I)
time frame: 0, 1, 2, 3, 6, 12, 18 and 24 months
description: Investigator-rated clinical global impression scale - severity and improvement
measure: ADHD Rating Scale
time frame: 0, 1, 2, 3, 6, 12, 18 and 24 months
description: Clinician-rated ADHD symptom scale
measure: Qb-test
time frame: 0, 1 and 12 months
description: Computerized ADHD-test
measure: WISC-IV
time frame: 0 and 12 months
description: Wechsler Intelligence Scale for Children
measure: Vineland scale
time frame: 0 and 12 months
description: Vineland parent interview of functioning
measure: Weiss Functional Impairment Scale (WFIRS)
time frame: 0, 12 and 24 months
description: Parent-rated function scale
measure: Child Health and Illness Profile - Child Edition (CHIP-CE)
time frame: 0, 12 and 24 months
description: Parent-rated quality of life scale
arm group label: Children and adolescents with ADHD
arm group type: Experimental
description: Children and adolescents medicating for ADHD of any subtype (presentation) with comorbidities
intervention type: Drug
intervention name: ADHD medications
arm group label: Children and adolescents with ADHD
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Mats Johnson, MD, PhD
role: Principal Investigator
affiliation: Child Neuropsychiatry Unit, Sahlgrenska University Hospital, Gothenburg, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No