NCT00255515已完成4 期
An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Social outcome measured by Strauss-Carpenter scale
研究概览
简要总结
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with 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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
- •Clinically stable and in an outpatient setting before entering the study (visit 1).
排除标准
- •Use of clozapine and quetiapine within two months prior to visit
- •If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.
研究组 & 干预措施
1
Experimental
quetiapine fumarate
干预措施: Quetiapine fumarate (Drug)
2
Active Comparator
Conventional treatment for schizophrenia
干预措施: conventional treatment for schizophrenia (Drug)
3
Experimental
quetiapine fumarate + Cognitive Remediation Therapy
干预措施: Quetiapine fumarate (Drug)
结局指标
主要结局
Social outcome measured by Strauss-Carpenter scale
时间窗: change from baseline to last visit and end of CRT
次要结局
- Change in PANSS total score(change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit)
- Change in PANSS positive, negative and general psychopathology symptom subscales(change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit)
- Change in cognition as measured by a Cognitive Battery of Tests(change from baseline to end of CRT and from baseline to last visit)
研究者
研究点 (1)
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