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

Lilly

Status and phase

Completed

Phase 4

Conditions

Bipolar Depression

Treatments

Drug: Olanzapine Fluoxetine Combination (OFC)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

H6P-MC-HDAX (Other Identifier)

12116

Details and patient eligibility

About

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)

Enrollment

291 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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