Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

NCT01303601 | Completed Phase 4 DMC

• 1 other identifier: MWang
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression, Bipolar

Keywords

Olanzapine; Monotherapy; bipolar Ⅰ depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  once weekly

Secondary Outcomes (5)

• 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

Study Arms (2)

olanzapine

EXPERIMENTAL

Drug: olanzapine

placebo

PLACEBO COMPARATOR

Drug: Starch

Interventions

olanzapine 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

olanzapine

Starch DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Department of Psychiatry, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine; Starch

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Man Wang, M.D.

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2009
• Study Completion: October 1, 2010
• Last Updated: February 25, 2011

Record last verified: 2008-12

Locations

CN (1)