Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- improvement of risk related symptoms
研究概览
简要总结
The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.
详细描述
The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.
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
- 14 Years 至 36 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria
- •Age between 14 and 36 years
- •male or female, in- or outpatients
- •written informed consent, for patients below 18 years also signed by parents
- •Special criteria (present within the last three months prior to the study)
- •Attenuated Positive Symptoms (APS)
- •Presence of at least one of the following symptoms: ideas of reference, odd beliefs or magical thinking, unusual perceptual experiences, odd thinking and speech, suspiciousness or paranoid ideation
- •Symptoms have to appear several times per week for a period of at least one week
- •Brief Limited Intermittent Psychotic Symptoms (BLIPS)
- •Duration of episode less than one week, interval between episodes at least one week
- •Symptoms resolve spontaneously
- •Presence of at least one of the following symptoms: Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior
排除标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of schizophrenia, schizophreniform,schizoaffective, delusional or bipolar disorder, at any time of life.
- •DSM-IV diagnosis of brief psychotic episode with a duration of more than one week, at any time time of life, or BLIPS within one week before inclusion.
- •DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances.
- •Abuse of alcohol or drugs within the last three months prior to the study; exception: cannabis user have to be drug-free during four weeks prior to the study. In case of drug abuse, it has to be determined, whether present prodromal symptoms appeared before any drug abuse; If not, symptoms have to be still present after a drug-free period of 3 months (hallucinogens, amphetamines), or four weeks (cannabis).
研究组 & 干预措施
supportive management
needs-focused, unspecific supportive management
干预措施: Supportive management (Behavioral)
amisulpride
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
干预措施: Amisulpride (Drug)
结局指标
主要结局
improvement of risk related symptoms
时间窗: 3, 6, 12, 24 months
Decrease of symptom scores; complete remission of risk related symptoms
次要结局
- Global functioning(3, 6, 12, 24 months)
研究者
Stephan Ruhrmann
Deputy Head of the Department of Psychiatry
University of Cologne