The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Efficacy Assessments
研究概览
简要总结
Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in patients with schizophrenia switched from other antipsychotics which were suboptimal due to insufficient efficacy or insufficient tolerability.
Methods:
This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) were eligible for the recruitment to the clinical trial.
- •They also fulfilled the criteria including having a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics due to insufficient efficacy or insufficient tolerability.
排除标准
- •Any DSM-IV-TR Axis I disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months
- •An imminent risk of suicide or a danger to self or others
- •Pregnancy or lactation
- •Intolerance or lack of response to quetiapine IR
- •Use of cytochrome P450 3A4 inhibitors or inducers in the 14 days preceding enrolment
- •Administration of a depot antipsychotic injection within one dosing interval before recruitment
- •Unstable or inadequately treated medical illness as judged by the investigator.
研究组 & 干预措施
Quetiapine XR
Patients had schizophrenia and fulfilled the criteria including having a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics due to insufficient efficacy or insufficient tolerability (N=61). They will receive the intervention of administration of quetiapine XR.
干预措施: Administration of quetiapine XR (Drug)
结局指标
主要结局
Efficacy Assessments
时间窗: 12 weeks
The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.
次要结局
- Safety Assessments(12 weeks)
研究者
Chin-Bin Yeh
Chief, Associate Professor, Department of Psychiatry
Tri-Service General Hospital