Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
olanzapine
干预措施: olanzapine (Drug)
placebo
干预措施: Starch (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale
时间窗: once weekly
次要结局
- 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)