<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/NCT01687478</url>
  </required_header>
  <id_info>
    <org_study_id>13702</org_study_id>
    <secondary_id>F1D-CR-HGNB</secondary_id>
    <nct_id>NCT01687478</nct_id>
  </id_info>
  <brief_title>A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression</brief_title>
  <official_title>A Study to Assess the Short-Term Efficacy and Safety of Olanzapine and Fluoxetine Compared to Placebo and Fluoxetine for Nonpsychotic Treatment-Resistant Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine&#xD;
      compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in&#xD;
      Chinese participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim assessment: Lack of efficacy&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score</measure>
    <time_frame>Baseline,8 Weeks</time_frame>
    <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)</measure>
    <time_frame>Baseline, 8 Weeks</time_frame>
    <description>AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Treatment Resistant Depression</condition>
  <arm_group>
    <arm_group_label>Olanzapine + Fluoxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olanzapine starting dose is 5 milligram (mg) (1 tablet). May titrate up to 10 mg (2 tablets), or 15 mg (3 tablets) administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Fluoxetine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
    <description>Administered Orally</description>
    <arm_group_label>Olanzapine + Fluoxetine</arm_group_label>
    <other_name>LY170053</other_name>
    <other_name>Zyprexa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine</intervention_name>
    <description>Administered Orally</description>
    <arm_group_label>Olanzapine + Fluoxetine</arm_group_label>
    <arm_group_label>Placebo + Fluoxetine</arm_group_label>
    <other_name>LY110140</other_name>
    <other_name>Prozac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered Orally</description>
    <arm_group_label>Placebo + Fluoxetine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have single or recurrent unipolar major depressive disorder (MDD) without psychotic&#xD;
             features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text&#xD;
             Revision (DSM-IV-TR) clinical assessment&#xD;
&#xD;
          -  Have a total score ≥22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at&#xD;
             screening and randomization&#xD;
&#xD;
          -  Have treatment-resistant depression (TRD), defined as having failed to achieve a&#xD;
             satisfactory antidepressant response, in the opinion of the investigator, to separate&#xD;
             treatment courses of at least 2 different antidepressants, other than fluoxetine, of&#xD;
             adequate dosage and duration (≥6 weeks) within the current major depressive episode&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of Parkinson's disease or a related disorder&#xD;
&#xD;
          -  Have a current or lifetime diagnosis of any of the following conditions, according to&#xD;
             DSM-IV-TR criteria: Schizophrenia; Schizophreniform Disorder; Schizoaffective&#xD;
             Disorder; Delusional Disorder; Psychotic Disorder Not Otherwise Specified; Bipolar&#xD;
             Disorder I or II; Delirium of any type; Dementia of any type; Amnestic Disorder; any&#xD;
             Substance-Induced Disorder; or any Psychotic Disorder due to a General Medical&#xD;
             Condition&#xD;
&#xD;
          -  Have a current diagnosis of post-partum depression or MDD with a seasonal pattern as&#xD;
             defined in the DSM-IV-TR&#xD;
&#xD;
          -  Have paranoid, schizoid, schizotypal, antisocial, or borderline personality disorder&#xD;
             (Axis II) as a comorbid or primary diagnosis, based on DSM-IV-TR criteria&#xD;
&#xD;
          -  Have DSM-IV-TR substance dependence/abuse or are not willing to avoid use of the&#xD;
             substance (not including dependence on nicotine or caffeine) within 30 days of&#xD;
             screening&#xD;
&#xD;
          -  Are actively suicidal in the judgment of the investigator&#xD;
&#xD;
          -  Have uncorrected narrow-angle glaucoma&#xD;
&#xD;
          -  Have had one or more seizures without a clear and resolved etiology&#xD;
&#xD;
          -  Have leukopenia&#xD;
&#xD;
          -  Have any acute, serious, or unstable medical conditions&#xD;
&#xD;
          -  Have an increased serum prolactin concentration at screening&#xD;
&#xD;
          -  Have a rate-corrected cardiac QT interval, calculated using Bazett's formula (QTc&#xD;
             Bazett's [Rate-corrected cardiac QT interval on electrocardiogram calculated using&#xD;
             Bazett's formula(QTcB)]), on Electrocardiogram (ECG) &gt;450 milliseconds (male) or &gt;470&#xD;
             milliseconds (female) at screening&#xD;
&#xD;
          -  Have a history of allergic reaction to olanzapine, fluoxetine, or olanzapine in&#xD;
             combination with fluoxetine&#xD;
&#xD;
          -  Have had treatment with olanzapine, fluoxetine, or olanzapine in combination with&#xD;
             fluoxetine withdrawn due to clinically significant and/or intolerable adverse effects&#xD;
             within 6 months of screening&#xD;
&#xD;
          -  Have received treatment with remoxipride within 6 months of randomization&#xD;
&#xD;
          -  Have received treatment with depot antipsychotics within one dosing interval before&#xD;
             randomization&#xD;
&#xD;
          -  Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS)&#xD;
             treatment within the current MDD episode, or has a history of failure to respond to&#xD;
             adequate treatment courses of ECT or VNS, or is expected to require ECT or VNS at any&#xD;
             time during the study&#xD;
&#xD;
          -  Have received previous treatment with clozapine&#xD;
&#xD;
          -  Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of&#xD;
             screening, or are expected to need MAOI treatment at any time during the study or up&#xD;
             until 5 weeks after study discontinuation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Baoding</city>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Beijing</city>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Changsha</city>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Guang Zhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kunming</city>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Xi'An</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Xinxiang</city>
        <zip>453002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>November 16, 2016</results_first_submitted>
  <results_first_submitted_qc>August 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2017</results_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Olanzapine + Fluoxetine</title>
          <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Fluoxetine</title>
          <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Entry Criteria Not Met</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Olanzapine + Fluoxetine</title>
          <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Fluoxetine</title>
          <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
        <group group_id="B3">
          <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="88"/>
            <count group_id="B2" value="88"/>
            <count group_id="B3" value="176"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.63" spread="12.18"/>
                    <measurement group_id="B2" value="41.45" spread="12.44"/>
                    <measurement group_id="B3" value="40.04" spread="12.36"/>
                  </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="41"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="99"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="176"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="176"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Montgomery-Äsberg Depression Rating Scale (MADRS) Total Score</title>
          <description>The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).</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="32.1" spread="5.3"/>
                    <measurement group_id="B2" value="31.8" spread="4.8"/>
                    <measurement group_id="B3" value="32.0" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>17 Item Hamilton Rating Scale for Depression (HAM-D17) Total Score</title>
          <description>The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (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="24.6" spread="2.6"/>
                    <measurement group_id="B2" value="25.0" spread="2.6"/>
                    <measurement group_id="B3" value="24.8" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Global Impressions-Severity of Depression (CGI-S)</title>
          <description>The CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).</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="4.9" spread="0.6"/>
                    <measurement group_id="B2" value="4.9" spread="0.7"/>
                    <measurement group_id="B3" value="4.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of First Major Depressive Disorder (MDD) Episode</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.92" spread="12.61"/>
                    <measurement group_id="B2" value="34.07" spread="12.69"/>
                    <measurement group_id="B3" value="30.00" spread="12.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years Since the First MDD Episode</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.71" spread="6.21"/>
                    <measurement group_id="B2" value="7.38" spread="7.86"/>
                    <measurement group_id="B3" value="8.05" spread="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years Since the Most Recent MDD Episode</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.66" spread="5.12"/>
                    <measurement group_id="B2" value="3.23" spread="4.15"/>
                    <measurement group_id="B3" value="3.45" spread="4.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Previous Lifetime MDD Episodes</title>
          <units>Number of MDD Episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.4" spread="1.4"/>
                    <measurement group_id="B2" value="1.3" spread="2.1"/>
                    <measurement group_id="B3" value="1.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Previous MDD Episodes Within the Last 36 Months</title>
          <units>Number of MDD Episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.5" spread="0.8"/>
                    <measurement group_id="B2" value="0.5" spread="1.1"/>
                    <measurement group_id="B3" value="0.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)</title>
        <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)</title>
          <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.</description>
          <population>Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</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="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.92" spread="1.20"/>
                    <measurement group_id="O2" value="-14.30" spread="1.28"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.04</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
            <estimate_desc>The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale</title>
        <description>CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale</title>
          <description>CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.</description>
          <population>Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</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="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="0.15"/>
                    <measurement group_id="O2" value="-1.63" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)</title>
        <description>SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)</title>
          <description>SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="1.71"/>
                    <measurement group_id="O2" value="-0.14" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)</title>
        <description>SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)</title>
          <description>SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.</description>
          <population>All randomized participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.20" spread="7.51"/>
                    <measurement group_id="O2" value="0.70" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.99" spread="11.79"/>
                    <measurement group_id="O2" value="3.93" spread="11.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.81" spread="12.05"/>
                    <measurement group_id="O2" value="0.02" spread="11.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" spread="11.49"/>
                    <measurement group_id="O2" value="2.84" spread="9.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.43" spread="13.54"/>
                    <measurement group_id="O2" value="5.04" spread="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.13" spread="13.55"/>
                    <measurement group_id="O2" value="4.56" spread="11.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-Emotional</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.61" spread="12.39"/>
                    <measurement group_id="O2" value="6.71" spread="12.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.98" spread="13.46"/>
                    <measurement group_id="O2" value="8.43" spread="11.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.87" spread="14.29"/>
                    <measurement group_id="O2" value="8.73" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.87" spread="7.59"/>
                    <measurement group_id="O2" value="-0.65" spread="7.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)</title>
        <description>SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)</title>
          <description>SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.</description>
          <population>All randomized participants.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Work/School (n=68,65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="2.71"/>
                    <measurement group_id="O2" value="-1.55" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Life (n=79,79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.70" spread="2.66"/>
                    <measurement group_id="O2" value="-1.49" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family Life (n=79,78)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.63" spread="3.00"/>
                    <measurement group_id="O2" value="-1.53" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDS Total Score (68,64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.57" spread="7.75"/>
                    <measurement group_id="O2" value="-4.41" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score</title>
        <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
        <time_frame>Baseline,8 Weeks</time_frame>
        <population>All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score</title>
          <description>The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
          <population>All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5"/>
                    <measurement group_id="O2" value="61.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks</title>
        <description>The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks</title>
          <description>The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.</description>
          <population>All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.9"/>
                    <measurement group_id="O2" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)</title>
        <description>BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)</title>
          <description>BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="2.24"/>
                    <measurement group_id="O2" value="-0.04" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)</title>
        <description>AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.</description>
        <time_frame>Baseline, 8 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Olanzapine + Fluoxetine</title>
            <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Fluoxetine</title>
            <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)</title>
          <description>AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.47"/>
                    <measurement group_id="O2" value="-0.31" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All participants in the safety analysis set.</desc>
      <group_list>
        <group group_id="E1">
          <title>Olanzapine + Fluoxetine</title>
          <description>Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.&#xD;
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Fluoxetine</title>
          <description>Placebo matches the Olanzapine tablet for blinding.&#xD;
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <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="55" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tongue disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hunger</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood prolactin increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Electrocardiogram t wave abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>High density lipoprotein decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Lipids increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypokinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="88"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphoria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Fear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Initial insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Somatic delusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01687478
org study id: 13702
secondary id: F1D-CR-HGNB
nct id: NCT01687478
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine
      compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in
      Chinese participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)
time frame: Baseline, 8 Weeks
description: The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.
measure: Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale
time frame: Baseline, 8 Weeks
description: CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.
measure: Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)
time frame: Baseline, 8 Weeks
description: SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.
measure: Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)
time frame: Baseline, 8 Weeks
description: SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.
measure: Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)
time frame: Baseline, 8 Weeks
description: SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.
measure: Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score
time frame: Baseline,8 Weeks
description: The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.
measure: Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks
time frame: Baseline, 8 Weeks
description: The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.
measure: Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)
time frame: Baseline, 8 Weeks
description: BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.
measure: Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)
time frame: Baseline, 8 Weeks
description: AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.
arm group label: Olanzapine + Fluoxetine
arm group type: Experimental
description: Olanzapine starting dose is 5 milligram (mg) (1 tablet). May titrate up to 10 mg (2 tablets), or 15 mg (3 tablets) administered once daily by mouth for 8 weeks.
Fluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.
arm group label: Placebo + Fluoxetine
arm group type: Placebo Comparator
description: Placebo matches the Olanzapine tablet for blinding.
Fluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.
intervention type: Drug
intervention name: Olanzapine
description: Administered Orally
arm group label: Olanzapine + Fluoxetine
other name: LY170053
other name: Zyprexa
intervention type: Drug
intervention name: Fluoxetine
description: Administered Orally
arm group label: Olanzapine + Fluoxetine
arm group label: Placebo + Fluoxetine
other name: LY110140
other name: Prozac
intervention type: Drug
intervention name: Placebo
description: Administered Orally
arm group label: Placebo + Fluoxetine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: China
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
mesh term: Olanzapine
mesh term: Fluoxetine
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
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reported events: 
certain agreements: 
point of contact: 