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

Official Title: “Study 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”

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)

Intervention(s) in this Clinical Trial

• 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
• Drug: Placebo
  • PO daily in the evening for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olanzapine/Fluoxetine Combination
• Placebo Comparator: Placebo

Primary Measures

• Children's Depression Rating Scale Revised (CDRS-R)
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 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
    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
    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
    Safety Issue?: No
• Mean change in Young Mania Rating Scale (YMRS)
  • Time Frame: 8 weeks
    Safety Issue?: No
• Mean change in Clinical Global Impression Scale - Bipolar Version (CGI-BP)
  • Time Frame: 8 weeks
    Safety Issue?: No
• Last Observation Carried Forward (LOCF) on CDRSR total score and individual items
  • Time Frame: 8 weeks
    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
    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
    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
    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
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in the clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00844857

Study ID Number: 12116

ClinicalTrials.gov Identifier: NCT00844857

Health Authority: United States: Food and Drug Administration