Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303601
• Other study ID #: MWang
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2011
• Last updated: February 24, 2011
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2008
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Outpatients with clinical diagnosis of bipolar?disorder

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

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
• Starch

Locations

Country	Name	City	State
China	Department of Psychiatry, the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale		once weekly	No
Secondary	The percentage of participants with a change in MADRS total score =50% from baseline as a measure of interventional response		once	No
Secondary	The percentage of participants with an endpoint (last observation available) MADRS total score =12 as a measure of interventional remission		once	No
Secondary	Young Mania Rating Scale		once weekly	No
Secondary	Clinical Global Impressions-Severity of Illness Scale		once weekly	No
Secondary	Clinical Global Impressions-Improvement Scale		once weekly	No