Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic
- •The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.
- •Subject has been treated with lithium in the past.
- •Subject has been treated with divalproex or carbamazepine in the past.
- •Subject has been treated with Haldol or haloperidol in the past.
排除标准
- •Subjects lacks the capacity to provide informed consent
- •Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
- •Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.
研究组 & 干预措施
Olanzapine
Subjects were be started on a standardized minimum first-day dose of 15 mg olanzapine. After the first day of therapy, the daily dose was either increased or decreased, as clinically indicated, by 5 mg, within an allowed range of 5 to 40 mg
干预措施: Olanzapine (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: Change from Baseline to End of Study
次要结局
未报告次要终点
研究者
Joseph Calabrese, MD
Director, Mood Disorders Program
University Hospitals Cleveland Medical Center