A Randomized, Double-Blind, Parallel-Group, Fixed Dose, Clinical Trial of Quetiapine 600 mg/Day vs 1200 mg/Day for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group
研究概览
简要总结
This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.
详细描述
The study will be conducted at two sites: Manhattan Psychiatric Center (MPC), and the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research/Rockland Psychiatric Center (NKI). A total of 60 patients will be enrolled, 30 at each location. After a screening period of 1 week, all patients will be entering an open label, four-week quetiapine treatment period (run-in phase), during which quetiapine will be titrated to 600 mg PO daily and other adjunctive antipsychotics will be gradually tapered and discontinued. Other concomitant medications such as mood stabilizers will be maintained, if their dose has been stable for the preceding 2 months. Patients not responding to quetiapine treatment at 600 mg PO (defined as reduction of < 15% change in Positive and Negative Syndrome Scale (PANSS) total score between start of run-in to end of week 4) during the run-in phase, will be eligible to enter the double blind phase. Study baseline will be Day 7 of Week 4 of the run-in phase. Patients qualifying for the double-blind phase will be randomly assigned to either high dose 1200 mg quetiapine daily (Group A) or to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double blind fashion for 8 weeks (Week 1 through Week 8 of double blind phase). Measures of extra-pyramidal side effects, psychopathology, and safety will be conducted throughout the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •DSM-IV criteria for chronic schizophrenia or schizoaffective disorder
- •Sub-optimal treatment-response
- •Total score > 60 on the Positive and Negative Syndrome Scale (PANSS) at baseline of run-in phase and again at baseline of double blind phase
- •Age 18-64 years old
- •Signed informed consent
- •Patient is in good general medical health
- •Exclusion criteria:
- •History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks
- •History of failure to respond to quetiapine treatment at dosages > 1200 mg daily for 6 contiguous weeks
- •History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)
- •Significant recent history of violence or suicidal activity, which required > 4 episodes of PRN anti-agitation medication per week
- •Mental retardation
- •Depot antipsychotic within 30 days before randomization
- •Significant medical illness requiring frequent dose adjustment or medication changes
- •Clozapine non-responders are explicitly excluded, as they would be unlikely to show a response in this study.
排除标准
- 未提供
研究组 & 干预措施
600 mg/day quetiapine (Group B)
Patients qualifying for the Double Blind Phase will be randomly assigned to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double-blind fashion for 8 weeks
干预措施: quetiapine (Drug)
1200 mg/day quetiapine (Group A)
Patients qualifying for the Double Blind Phase will be randomly assigned to high dose 1200 mg quetiapine daily (Group A) on the assigned dose in a double-blind fashion for 8 weeks
干预措施: quetiapine (Drug)
结局指标
主要结局
To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group
时间窗: 8 weeks
次要结局
- To see if treatment with quetiapine 1200 mg per day will improve total PANSS more robustly than quetiapine 600 mg per day(8 weeks)
研究者
Jean-Pierre Lindenmayer
Clinical Director
Manhattan Psychiatric Center