Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Psychotic Symptoms
研究概览
简要总结
This project focuses on the under-researched group of individuals who develop psychotic episodes of short duration (less than four weeks) while using substances. This includes individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is known about the most appropriate maintenance/relapse prevention management of these subjects. These individuals are not diagnosed with a primary psychosis because psychotic symptoms are too short-lived or non-specific, the onset of substance use precedes the onset of psychotic symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of substance use. However, previous studies have shown that they are at high risk of recurrence of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic episode of short duration associated with substance use. The investigators will compare aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing substance use during a 6-month maintenance phase.
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
- 16 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-defined diagnosis of psychosis NOS or substance-induced psychosis assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- •onset of psychotic symptoms following onset of substance use
- •current DSM-IV-defined diagnosis of substance abuse or dependence assessed with the SCID-I/P
- •duration of the acute psychotic episode less than 4 weeks
- •aged 16 to 44
- •competent and willing to sign informed consent
- •for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control and not to become pregnant during the study
- •at the entry of the maintenance phase, remission of psychotic symptoms defined as 1) simultaneous ratings of <3 ("mild) on all of the following Brief Psy¬chiatric Rating Scale-Anchored version items (BPRS-A; Woerner et al. 1988): suspiciousness, unusual thought content, hallucinations, conceptual disorganization; and 2) a Clinical Global Impressions Scale (CGI; Guy 1976) Se-verity rating of 3 ("mild") or less.
排除标准
- •DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, shared psychotic disorder, or a major mood disorder (major depression or bipolar mania) with psychotic features
- •antipsychotic treatment for more than six months prior to enrollment
- •serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- •medical condition that requires treatment with a medication that has psychotropic effects
- •significant risk of suicidal or homicidal ideation or behavior
- •cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures
- •history of treatment resistance to aripiprazole
- •medical contraindications to aripiprazole
- •hypersensitivity to aripiprazole or any component of the products.
研究组 & 干预措施
Aripiprazole
干预措施: Behavioral Intervention (Behavioral)
Placebo
干预措施: Behavioral Intervention (Behavioral)
结局指标
主要结局
Psychotic Symptoms
时间窗: 7 months
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale. We will focus on time to first recurrence of psychotic symptoms and rate of recurrence.
Frequency/amount of substance use
时间窗: 7 months
Frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method. We will focus on time to first recurrence of substance use and rate of recurrence.
次要结局
- Mood symptoms(7 months)
- Adverse Events(7 months)