A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment And Maintenance Of Response In Patients With Acute Mania
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
- •A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).
排除标准
- •Have a diagnosis of learning disability or organic brain syndrome.
- •Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
研究组 & 干预措施
A
干预措施: ziprasidone hydrochloride (Drug)
B
干预措施: olanzapine (Drug)
结局指标
主要结局
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
时间窗: 4 weeks
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
次要结局
- Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.(4, 6 and 10 weeks)
- Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.(up to 10 weeks)
- Time to Symptomatic Remission in the Double Blind Phase.(up to 10 weeks)
- Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.(6 months)
- Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.(6 weeks)
- Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.(6 months)