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Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

NCT ID: NCT01303601

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-10-31

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.

Conditions

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Bipolar Disorder Depression, Bipolar

Keywords

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Olanzapine Monotherapy bipolar Ⅰ depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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olanzapine

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Starch

Intervention Type DRUG

Interventions

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olanzapine

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

Intervention Type DRUG

Starch

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Principal Investigators

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Man Wang, M.D.

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Locations

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Department of Psychiatry, the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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MWang

Identifier Type: -

Identifier Source: org_study_id