Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
研究概览
简要总结
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
- •Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
排除标准
- •Have received an antidepressant or a psychostimulant within 5 days prior to Visit
- •The duration of the current episode is more than 90 days at Visit
- •Have a history or a diagnosis of diabetes mellitus.
- •Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
研究组 & 干预措施
Olanzapine
olanzapine: 5 to 20 mg per day for 6 weeks
干预措施: olanzapine (Drug)
Haloperidol
haloperidol: 2.5 to 10 mg per day for 6 weeks
干预措施: haloperidol (Drug)
Placebo
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
时间窗: Baseline, 3 weeks
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
次要结局
- Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)(Baseline, 6 weeks)
- Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)(6 weeks)
- Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness(Baseline, 6 weeks)
- Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale(Baseline, 3 weeks, 6 weeks)
- Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks(Baseline, 3 weeks, 6 weeks)
- Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks(3 weeks, 6 weeks)
- Percentage of Participants Who Switched to Symptomatic Depression(3 weeks, 6 weeks)
- Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)(Baseline, 3 weeks, 6 weeks)
- Percentage of Participants Who Switched to Syndromic Depression(3 weeks, 6 weeks)
- Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score(Baseline to 6 weeks)