EUCTR2009-012031-15-RO进行中（未招募）1 期
The Switch study
Technische Universitaet Munchen, vertreten durch das Klinikum rechts0 个研究点目标入组 327 人开始时间: 2011年6月16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
- 327
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
- 性别
- All
入选标准
- •1. Male or female inpatients, 18 to 65 years of age. 2. Participants must have a diagnosis of schizophrenia, or schizophreniform disorder or schizoaffective disorder as defined in DSM-IV TR, verified by the M.I.N.I. interview at screening. 3. At study entry a Positive and Negative Syndrome Scale (PANSS, Kay et al. 1987) total score of at least 75 AND a score of = 4 on any two of the items of the positive component factors (i.e. delusions, unusual thought content, hallucinatory behaviour, suspiciousness, grandiosity, lack of judgement and insight) AND at least a rating of 4 = moderately ill according to the Clinical Global Impression Scale (Guy 1976) to assure that participants are symptomatic. 4. Increase in the level of care due to current acute episode (i.e. outpatient care to inpatient or day-clinic care) and this increase in care took place no longer than 3 working days before study entry 5. Able to give informed consent. 6. The criterion for the second randomisation is less than 25% Positive and Negative Syndrome Scale (PANSS, Kay et al. 1987) total score reduction from baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Contraindications for amisulpride or olanzapine (allergies, pregnancy etc). 2. Known treatment resistance to study drugs as defined by the American/German/World Federation of Biological Psychiatry schizophrenia practice guidelines (Falkai et al. 2005, Lehman et al. 2004, Gaebel et al. 2006): insufficient response despite a trial of at least 4 to 6 weeks duration with sufficient doses (olan-zapine 15-20mg/day, amisulpride 600-800 mg/day), and despite appropriate compliance. 3. Continuous treatment with study drugs in sufficient doses (olanzapine 15-20mg, amisulpride 600-800mg) and with adequate compliance in the 2 weeks before study entry 4. Increase in the level of care (outpatient care to inpatient or day-clinic care) due to social reasons or side effect burden or >3 working days prior to study entry for any reason 5. Current acute episode remained on a clinically unchanged level for 4 weeks prior to study entry despite adequate treatment and sufficient compliance with the treatment 6. Received depot antipsychotic within 1 dose interval before inclusion, in the case of risperidone Consta last injection within 5 weeks (long half life of depots which would interact with study drugs, risperidone consta has a special metabolism). 7. Actively suicidal (double-blind treatment unethical). 8. Pregnancy (antipsychotic drug treatment very problematic). 9. Patients with an DSM-IV TR diagnosis of a substance dependence (abuse is allowed to enhance gener-alisability) other than nicotine or caffeine within 3 months prior to baseline (these substances can interact with study drugs). 10. Serious medical illnesses (double-blind psychotropic medication unethical)
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