A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression

Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 13, 2009)
Children's Depression Rating Scale Revised (CDRS-R) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00844857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 13, 2009)
  • Rate of response and time to response as determined by greater than or equal to 50% reduction from Baseline on CDRS-R total score AND a score of less than or equal to 2 on Young Mania Rating Scale (YMRS) item 1 [Elevated Mood] score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Rate of remission and time to remission as determined by a CDRS-R total score of 28 or less, YMRS total score of 8 or less, AND Clinical Global Impression Scale-Bipolar Version (CGI-BP) total score of less than or equal to 3 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Level of improvement of bipolar disorder as determined by percentage reduction from Baseline on CDRS-R total score and YMRS item 1 [Elevated Mood] score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean change in Young Mania Rating Scale (YMRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean change in Clinical Global Impression Scale - Bipolar Version (CGI-BP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Last Observation Carried Forward (LOCF) on CDRSR total score and individual items [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparing incidence of extrapyramidal symptoms (EPS) using Barnes Akathisia Rating Scale, Abnormal Involuntary Movements Scale (AIMS), and Simpson-Angus Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Comparing the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the treatment period using Columbia Suicide-Severity Rating Scale (CSSRS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Evaluating the difference in the incidence of worsening of manic symptoms as measured by YMRS total score and CGI-BP Severity of Mania score. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Assess the treatment effects associated with comorbidity of Attention-Deficit/Hyperactivity Disorder (ADHD) as determined by Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Assess the health-related quality of life using the Quality of Life Questionnaire for Children and Adolescents (KINDL®; both the patient and parent questionnaires) and assess hospitalization rates using the Lilly Healthcare Services Information Module [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Official Title  ICMJEStudy to Access the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar Disorder
Brief Summary

The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.

  • Can this study drug make children with bipolar depression feel better?
  • Does this study drug work better than a placebo (sugar pill)?
  • Does this study drug cause side effects in children who take it?
  • Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEBipolar Depression
Intervention  ICMJE
  • Drug: Olanzapine Fluoxetine Combination
    (Olanzapine/Fluoxetine doses are capsules of 3/25, 6/25, 12/25, 6/50, or 12/50mg) to be taken PO once daily in the evening for 8 weeks
    Other Names:
    • LY900000
    • Symbyax
  • Drug: Placebo
    PO daily in the evening for 8 weeks
Study Arms / Comparison Groups
  • Olanzapine/Fluoxetine Combination: Experimental
    Intervention: Drug: Olanzapine Fluoxetine Combination
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE300
Estimated Completion DateNovember 2011
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female inpatients or outpatients, 10-17 yrs of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20kg at screening.
  • Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR, and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
  • Patients entering the study will also be scored by the CDRS R (entry score of greater than or equal to 40) as well as the adolescent-structured YMRS (entry score of less than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).

Exclusion Criteria:

  • Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
  • Have an acute, serious or unstable medical condition
  • Have clinically significant laboratory abnormalities
  • Have had one or more seizures of unclear etiology
  • Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed
Ages10 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in the clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Mexico,   Puerto Rico,   Russian Federation,   Turkey

Administrative Information

Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE12116, H6P-MC-HDAX
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
Study Director: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)Eli Lilly and Company
Information Provided ByEli Lilly and Company