Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

China Medical University, China68 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bipolar Disorder Depression, Bipolar

Interventions

olanzapineDRUG

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

StarchDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, the First Hospital of China Medical University

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale

Time frame: once weekly

Secondary Outcomes

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

Time frame: once

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

Time frame: once

Young Mania Rating Scale

Time frame: once weekly

Clinical Global Impressions-Severity of Illness Scale

Time frame: once weekly

Clinical Global Impressions-Improvement Scale

Time frame: once weekly

Data from ClinicalTrials.gov

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