A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Olanzapine Fluoxetine Combination (OFC); Placebo
Intervention description: OFC doses are capsules of 3 milligrams (mg) olanzapine and 25 mg fluoxetine (3/25), 6/25, 12/25, 6/50, or 12/50 mg to be taken orally once daily in the evening for 8 weeks.; Orally, once daily in the evening for 8 weeks.
Intervention MeSH terms: Olanzapine; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar I Depression

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)
    

Eligibility criteria:

        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