Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 107
研究概览
简要总结
The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.
详细描述
This trial will consist of 1600 patients with schizophrenia for whom a medication change may be indicated for reasons of limited efficacy or tolerability. All patients will receive some psychosocial treatment through study participation. Research participants and their family members will be offered psychosocial interventions directed at improving patient and family understanding of the illness, decreasing the burden of illness in the family, maximizing treatment adherence, minimizing relapse, enhancing access to a range of community-based rehabilitative services and improving study retention.
Phase I: Patients will be randomly assigned to one of five treatment conditions for up to 18 months:
- 320 begin double-blind treatment with perphenazine (PER)
- 320 begin double-blind treatment with olanzapine (OLZ)
- 320 begin double-blind treatment with quetiapine (QUET)
- 320 begin double-blind treatment with risperidone (RIS)
- 220 begin double-blind treatment with ziprasidone (ZIP)
Phase IA: 100 patients screened and found to have tardive dyskinesia who would otherwise be eligible for the study will be randomly assigned to one of the four atypical drugs in Phase IA.
Phase IB: Patients who fail treatment with perphenazine in Phase I will be randomly assigned to olanzapine, quetiapine, or risperidone in Phase IB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •18-65 years old
- •DSM-IV diagnosis of schizophrenia
- •adequate capacity to consent
- •Intolerance or failure to respond to one of the treatments
- •Diagnoses of schizoaffective disorder, mental retardation, pervasive developmental disorder, delirium, dementia, amnesia
- •First episode of schizophrenia
- •Women currently pregnant or breast-feeding
排除标准
- 未提供