Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

February 24, 2011 updated by: China Medical University, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Department of Psychiatry, the First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Starch
Experimental: olanzapine
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Investigators

  • Study Director: Man Wang, M.D., First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

February 25, 2011

Last Update Submitted That Met QC Criteria

February 24, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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