Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

Official Title
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Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained. Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode. Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Exclusion Criteria: Female patients who are either pregnant or nursing. Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months. Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment. Patients who have been judged clinically to be serious suicidal risks.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall) |  |  | 
| Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS). |  |  | 
| Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo. |  |  | 
| Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment |  |  |