EUCTR2009-012031-15-DE进行中（未招募）不适用
The switch study - efficacy of early antipsychotic switch versus maintenance in patients with schizophrenia poorly responding to two weeks of antipsychotic treatment - The SWITCH-study
Technische Universitaet Muenchen, vertreten durch das Klinikum rechts der Isar0 个研究点开始时间: 2009年7月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •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).
研究者
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