A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
研究概览
简要总结
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
- •Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- •PANSS total score of at least 70 at enrolment and at assignment Day 1
- •CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks
排除标准
- •Known intolerance or lack of response to quetiapine fumarate
- •Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
- •Substance or alcohol dependence at enrolment
- •Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
研究组 & 干预措施
Quetiapine Fumarate XR
Seroquel XR 400-800mg
干预措施: Quetiapine Fumarate XR (Drug)
结局指标
主要结局
The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
时间窗: From baseline to Day 57
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210. Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method
次要结局
- Positive and Negative Syndrome Scale (PANSS) Positive Score(From baseline to Day 57)
- Positive and Negative Syndrome Scale (PANSS) Negative Score(From baseline to Day 57)
- Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score(From baseline to Day 57)
- Clinical Global Impression (CGI) Score(From baseline to Day 57)
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(From baseline to Day 57)
- Global Assessment of Functioning (GAF) Score(From baseline to Day 57)