Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Sponsor

China Medical University, China (Other)

Overall Status

Completed

CT.gov ID

NCT01303601

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Depression, Bipolar	Drug: olanzapine Drug: Starch	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: placebo	Drug: Starch

Arm

Intervention/Treatment

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

Placebo Comparator: placebo

Drug: Starch

Outcome Measures

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale [once weekly]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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