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A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression - NCT00844857-32611(Clinical Trial 272304)



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City:  Gainesville
State:  
FL
Zip Code: 32611
Conditions: Bipolar Depression
Purpose: 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)
Study summary:
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
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