Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
2014年12月23日 更新者:Stephan Ruhrmann、University of Cologne
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
124
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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North Rhine-Westphalia
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Cologne、North Rhine-Westphalia、德国、50924
- Department of Psychiatry and Psycotherapy University of Cologne
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 36年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
AND / OR
- 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
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:supportive management
needs-focused, unspecific supportive management
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The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need.
Regular psychotherapy was not permitted.
其他名称:
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实验性的:amisulpride
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
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Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps.
As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present.
The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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improvement of risk related symptoms
大体时间:3, 6, 12, 24 months
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Decrease of symptom scores; complete remission of risk related symptoms
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3, 6, 12, 24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Global functioning
大体时间:3, 6, 12, 24 months
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Increase of Global Assessment of Functioning (GAF) scores
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3, 6, 12, 24 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅:Joachim Klosterkötter, Professor、Department of Psychiatry and Psycotherapy University of Cologne
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2001年1月1日
初级完成 (实际的)
2005年6月1日
研究完成 (实际的)
2005年6月1日
研究注册日期
首次提交
2005年9月12日
首先提交符合 QC 标准的
2005年9月12日
首次发布 (估计)
2005年9月20日
研究记录更新
最后更新发布 (估计)
2014年12月24日
上次提交的符合 QC 标准的更新
2014年12月23日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Supportive management的临床试验
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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的