NCT00712686已完成3 期
A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 690
- 主要终点
- The mean change in the PANSS Total Score
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia
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 (Participant, Investigator)
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
- •Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
- •Treated as outpatients for at least one continuous 3-month period during the past 12 months
- •PANSS total score ≥60
- •Previously responsive to neuroleptics (other than clozapine)
- •Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements
排除标准
- •An Axis I (DSM-IV) diagnosis of schizoaffective disorder
- •A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
- •Nonresponsive to prior olanzapine therapy
- •Likely to require prohibited concomitant therapy
- •DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
- •Known to be allergic or hypersensitive to study drugs
- •Represented a significant risk of committing suicide based on history or mental status exam
- •Unstable thyroid pathology and treatment within the past six months
- •A history or evidence of a medical condition that would expose the patient to an undue risk
- •Clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ECG findings
研究组 & 干预措施
B1
Active Comparator
干预措施: Olanzapine (Drug)
A1
Active Comparator
干预措施: Aripiprazole (Drug)
结局指标
主要结局
The mean change in the PANSS Total Score
时间窗: from baseline to Week 6
The percentage of patients showing significant weight gain (a≥ 7% increase)
时间窗: from baseline to Week 26
次要结局
- Change from baseline on the CGI-S Score(at the end of study)
- Change from baseline on PANSS Total Score(at the end of study)
- Change from baseline on PANSS-Negative Scale Total Score(at the end of study)
- Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score(at the end of study)
- Mean CGI-I Score(at the end of study)
- Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)(at the end of study)
- Change from baseline on the MADRS(at the end of study)
- Change from baseline on PANSS-Positive Scale Total Score(at the end of study)
- Safety and tolerability(at the end of study)
研究者
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终止
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