Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Phase 4

Completed

• Conditions: Bipolar Disorder; Depression, Bipolar
• Interventions: Drug: olanzapine; Drug: Starch

• Registration Number: NCT01303601
• Lead Sponsor: China Medical University, China

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-12
• Study Start: 2009-01
• Study Completion: 2010-10
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Last Update Submitted: 2011-02-24
• Study First Posted: 2011-02-25
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olanzapine	olanzapine	-
placebo	Starch	-

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale	once weekly

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Psychiatry, the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China