EUCTR2010-022463-35-GB进行中(未招募)1 期
The Benefit of Minocycline on Negative Symptoms in Psychosis: Extent and Mechanisms - The Benefit of Minocycline on Negative Symptoms in Psychosis (BeneMin)
Manchester Mental Health and Social Care Trust0 个研究点目标入组 170 人开始时间: 2011年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Male or female aged 16-35 years 2) Current DSMIV diagnosis of schizophrenia, schizophreniform or schizo-affective psychosis, psychosis NOS as assessed with the clinical team. 3) In an episode as defined by a) an onset or exacerbation of symptoms and b) with continuing positive symptoms scoring at least mild (>2) on items P1,P2 or P6 of the PANSS within the last month 4) In contact with early intervention, community or in-patient services, 5) Within 3 years of onset of symptoms 6) Current IQ greater than 70 7) Female patients must use effective birth control with a negative pregnancy test 8) Able to understand and willing to give written informed consent 9) Fluent in English
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Current substance misuse diagnosis that in the opinion of the investigator may interfere with the study. Urine toxicology screens will be used to monitor drug use. 2) Patients who, in the Investigator’s judgment pose a current serious suicidal or violence risk 3) Prior tetracycline use within 2 months of baseline visit or history of sensitivity or intolerance 4) History of systemic lupus erythematosis (SLE) or a history of SLE in a first-degree relative 5) Use of any investigational drug within 30 days of baseline visit 6) Relevant current or past haematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the investigator may interfere with the study 7) Clinically significant deviation from the reference range in clinical laboratory test results as judged by the Investigator. 8) Previous randomisation in the present study. 9) Pregnant or nursing.
研究者
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