Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Study Overview
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Brief Summary
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Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. The investigators conducted a randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for treatment of the depressed phase of bipolar disorder.

Detailed Description
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The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.68 patients were randomized to assigned 6 weeks by olanzapine or placebo. Medications were provided in double-blind fashion. The assessments include Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, clinical Global Impressions-Severity of Illness scale, Clinical Global Impressions-Improvement scale, response and remission rates, and Treatment Emergent Symptom Scale.

Official Title
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Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study

Conditions
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Bipolar Disorder, Depression, Bipolar

Intervention / Treatment
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* Drug: olanzapine
* Drug: Starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with clinical diagnosis of bipolarⅠdisorder MADRS total score ≥ 20 CGI-S rating ≥ 4 Normal results of physical examinations, laboratory and electrocardiogram tests Being taken care of by a guardians during the trial Exclusion Criteria: Pregnant or lactating women YMRS total score ≥ 15 Treatment with olanzapine within 3 months prior to study entry Retrospective history of poor antidepressive response to or intolerance of olanzapine Mental retardation Addictive disorder Diabetes mellitus Dyslipidaemia Cardiovascular diseases Hypertension

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olanzapine<br> | Drug: olanzapine<br>* Tablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated. daily 6 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: Starch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale |  | once weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response |  | once | 
| The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission |  | once | 
| Young Mania Rating Scale |  | once weekly | 
| Clinical Global Impressions-Severity of Illness Scale |  | once weekly | 
| Clinical Global Impressions-Improvement Scale |  | once weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olanzapine, Monotherapy, bipolar Ⅰ depression