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Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Primary Purpose

Bipolar Disorder, Depression, Bipolar

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

olanzapine

Starch

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Olanzapine, Monotherapy, bipolar Ⅰ depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Psychiatry, the First Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

olanzapine

placebo

Arm Description

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response

The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission

Young Mania Rating Scale

Clinical Global Impressions-Severity of Illness Scale

Clinical Global Impressions-Improvement Scale

Full Information

NCT ID

NCT01303601

First Posted

February 24, 2011

Last Updated

February 24, 2011

Sponsor

China Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT01303601

Brief Title

Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

China Medical University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Depression, Bipolar

Keywords

Olanzapine, Monotherapy, bipolar Ⅰ depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

olanzapine

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

olanzapine

Intervention Description

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

Intervention Name(s)

Starch

Primary Outcome Measure Information:

Title

Montgomery-Asberg Depression Rating Scale

Time Frame

once weekly

Secondary Outcome Measure Information:

Title

The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response

Time Frame

once

Title

The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission

Time Frame

once

Title

Young Mania Rating Scale

Time Frame

once weekly

Title

Clinical Global Impressions-Severity of Illness Scale

Time Frame

once weekly

Title

Clinical Global Impressions-Improvement Scale

Time Frame

once weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Man Wang, M.D.

Organizational Affiliation

First Hospital of China Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Psychiatry, the First Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

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