NCT00520650已完成4 期
Health Evaluation of Abilify Long-term Therapy
Taiwan Otsuka Pharm. Co., Ltd11 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 11
- 主要终点
- Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
研究概览
简要总结
This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.
详细描述
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients between the ages of 18 to
- •Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
- •Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
排除标准
- •Pregnant or breast feeding women or planning a pregnancy.
- •Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
- •A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
- •Patient has clinically relevant organic, neurological, or cardiovascular diseases.
- •Patient has a history of drug or alcohol abuse within the last 12 weeks.
- •Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
- •Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
- •Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
- •Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
结局指标
主要结局
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
时间窗: Throughout the study
次要结局
- Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.(Throughout the study)
- Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.(Throughout the study.)
- Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.(Throughout the study.)
- Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.(throughout the study)
- Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.(Throughout the study.)
- Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.(Throughout the study.)
- CGI-I scores after 12, 26, 39, and 52 weeks of treatment.(Throughout the study.)
研究者
研究点 (11)
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