Clinical trial NCT01303601: Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression
Official title: Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Depression, Bipolar
Keywords: Olanzapine
Monotherapy
bipolar Ⅰ depression
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: once weekly
Secondary outcomes:
measure: The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response
timeFrame: once
measure: The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission
timeFrame: once
measure: Young Mania Rating Scale
timeFrame: once weekly
measure: Clinical Global Impressions-Severity of Illness Scale
timeFrame: once weekly
measure: Clinical Global Impressions-Improvement Scale
timeFrame: once weekly
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Psychiatry, the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Man Wang, M.D.
role: STUDY_DIRECTOR
References: