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

Study to Assess 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 I 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)

Inclusion Criteria:

• Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) 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, Fourth Edition, Text Version (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 Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (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