Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression

Study Overview
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Brief Summary
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The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.

Official Title
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Olanzapine/Fluoxetine Combination Versus Lamotrigine in the Treatment of Bipolar I Depression

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Fluoxetine
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, 18 to 60 years of ages, inpatients or outpatients. Inpatients are qualified only if they are hospitalized for current episode of bipolar depression and should be able to leave hospital when clinical criteria are no longer met for acute inpatient hospitalization Patients must fulfill the criteria for bipolar I depression (bipolar I disorder, current episode major depressive) as defined in DSM-IV-TR based on clinical examination and psychiatric assessment Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode as defined in DSM-IV-TR, of sufficient severity to require treatment with a mood stabilizer or an antipsychotic as reported by the patient or the caregiver Each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol Female patients must test negative for pregnancy and must be using a medically accepted means of contraception Exclusion Criteria: Current diagnosis of any of the following according to DSM-IV-TR criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Delirium of any type, Dementia 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 previously misdiagnosed. Treatment with clozapine within 3 months (90 days) prior to visit 1 Treatment with electroconvulsive therapy (ECT) within 3 months (90 days) prior to visit 2 Patients with seizure disorders are excluded (except patients with a previous history of seizures due to alcohol withdrawal, which have resolved). Participation in a clinical trial of another drug including olanzapine, fluoxetine or lamotrigine within 30 days prior to study entry (visit 1)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Fluoxetine|nan|
|Drug: Lamotrigine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine in the treatment of patients with bipolar I depression during the first 7 weeks of therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine on depressive symptoms |  |  | 
| Assess the onset of action of olanzapine/fluoxetine combination compared with lamotrigine as measured by time to achieve an initial response |  |  | 
| Assess the study-defined response and remission rates including time to achieve a full response and time to achieve remission as well as time to sustained response and sustained remission |  |  | 
| Assess the time to and rate of relapse to depressive episode following remission for olanzapine/fluoxetine combination compared with lamotrigine |  |  | 
| Assess the time to and rate of relapse to mania with olanzapine/fluoxetine combination compared with lamotrigine |  |  | 
| Assess efficacy of treatment in improving symptomatology |  |  | 
| Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period |  |  | 
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine for suicide ideation |  |  | 
| Assess the total time of hospitalization of patients on olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period |  |  | 
| Assess the safety and tolerability of olanzapine/fluoxetine combination compared with lamotrigine during 6 months of therapy |  |  | 
| The sensitivity and positive predictive value of the MDQ will be determined in this study, using the SCID as a standard |  |  | 
| To explore possible correlation between changes in eating behavior and changes in body weight |  |  |