Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequencies of positive urine drug screens and breathalyzer alcohol levels
研究概览
简要总结
The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; The investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; The investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; The investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age, male or female (post-menopausal, surgically sterilized, or receiving either one of the listed contraception - depot contraceptive, Intrauterine device, or implanted hormonal contraceptive),
- •who meet DSM-V criteria for schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, depression with psychotic features, or delusional disorder, and have ratings of Moderate or greater on at least one of the Brief Psychiatric Rating Scale psychosis items,
- •who meet DSM-V criteria for at least one of alcohol, marijuana, cocaine, stimulant, or opioid use disorder, and have an admission urine drug screen positive for at least one of these substances,
- •who have a stable living situation (family or supervised living, e.g. personal care home) to return to after release into the community,
- •and who provide signed informed consent to participate (after testing for comprehension).
排除标准
- •Prior failure to respond or tolerate clozapine or olanzapine
- •Logistics that prevent outpatient follow-up at Serenity Behavioral Health Adult Outpatient services
研究组 & 干预措施
Clozapine Arm
干预措施: Clozapine (Drug)
Olanzapine Arm
干预措施: Olanzapine (Drug)
结局指标
主要结局
Frequencies of positive urine drug screens and breathalyzer alcohol levels
时间窗: 12 weeks
Participants will have weekly urine drug screens and alcohol level measurement using breathalyzer to monitor ongoing substance and alcohol abuse.
次要结局
- All-cause treatment discontinuation(12 weeks)
- Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items(12 weeks)
研究者
Sandarsh Surya
Assistant Professor, Department of Psychiatry and Health Behavior
Augusta University