Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

Study Overview
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Brief Summary
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The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.

Official Title
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Olanzapine Versus Lithium Carbonate in the Treatment of Bipolar Disorder, Manic or Mixed Episodes

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Olanzapine Hydrochloride
* Drug: Lithium Carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female in- or out-patients at least 18 years of age Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2 Patients must be considered reliable Exclusion Criteria: Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV Documented history of intolerance to olanzapine or Lithium Carbonate Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2

Ages Eligible for Study
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Minimum Age: 18 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 Hydrochloride|nan|
|Drug: Lithium Carbonate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the efficacy of olanzapine once a day orally for 4 weeks to Lithium Carbonate orally in the treatment of Chinese patients with bipolar I disorder, manic or mixed episodes, with or without psychotic features as measured by the CGI-BP Severity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the Y-MRS |  |  | 
| Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the BRPs, MADRS. |  |  | 
| Assess the safety of olanzapine compared with Lithium Carbonate. Treatment-emergent adverse events, change in vital signs, laboratory analytes and ECG will be measured. |  |  |