Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •Current Hospitalization or outpatient relapse
- •Fewer than four previous admissions
- •Willing to accept long-acting injectable treatment and participate in rehabilitation
排除标准
- •Primary diagnosis other than schizophrenia
- •Prior Long Acting Injectable treatment
- •Current Suicide Risk
- •Hypersensitivity to Aripiprazole
- •Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases)
- •Unable to give personal informed consent
- •History of treatment resistance as evidenced by clozapine treatment
- •Unable to stop treatment with medications that are strong Cytochrome (CYP) 2D6 or CYP 3A4 inhibitors and or strong CYP3A4 inducers (2.3, 7.1) for at 14 days prior to initiation.
研究组 & 干预措施
Aripiprazole and Computerized Cognitive and Functional Skills Training Group
Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation.
干预措施: Aripiprazole Lauroxil (Drug)
Aripiprazole and Computerized Cognitive and Functional Skills Training Group
Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation.
干预措施: Computerized cognitive and functional skills training (Behavioral)
结局指标
主要结局
The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS)
时间窗: 6 months
PANSS has 6 critical items with each item being scored from 1 to 7 with the higher score indicating more severe symptoms. A score of 3 or less on all six critical items defines the presence of remission.
次要结局
未报告次要终点
研究者
Dante Durand
Associate Professor of Psychiatry
University of Miami