Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study|
- Montgomery-Asberg Depression Rating Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
- The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response [ Time Frame: once ] [ Designated as safety issue: No ]
- The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission [ Time Frame: once ] [ Designated as safety issue: No ]
- Young Mania Rating Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
- Clinical Global Impressions-Severity of Illness Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
- Clinical Global Impressions-Improvement Scale [ Time Frame: once weekly ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||October 2010|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303601
|Department of Psychiatry, the First Hospital of China Medical University|
|Shenyang, Liaoning, China, 110001|
|Study Director:||Man Wang, M.D.||China Medical University, China|