DRKS00008750已完成2 期
Add-on spironolactone for the treatment of schizophrenia - SPIRO-TREAT
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 90 人开始时间: 2015年6月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Male and female (with contraception) patients with schizophrenia (ICD-10 Criteria), no longer in acute phase of illness (PANSS Total = 75, CGI = 4), duration of illness > 6 months, guideline-based ongoing antipsychotic treatment in monotherapy or in combination treatment with maximum two antipsychotics if clinically required, stable medication for at least one week, aged 18 to 65, capacity to consent
- •Following a major protocol adaption, female subjects were also permitted (approved by IRB of LMU, 04.10.2016).
排除标准
- •Pregnancy, no contraception, current suicidality as well as injuries to others, severe neurological and internistic comorbidities, known and assumed non-compliance regarding intake of medication, current antipsychotic therapy with clozapine, antipsychotic treatment with a fully renal eliminable compound (amisulprid), known clinical necessity of antipsychotic combination treatment, no new dosing of mood stabilisers or antidepressants during 3-week intervention phase. An already existing mood stabiliser therapy (excluding lithium) or antidepressant therapy (excluding renal eliminable antidepressant) can be continued in unaltered dose. Alcohol- or substance abuse during the last 6 months before inclusion into study; nicotine and coffee are excluded. Epileptic seizures in anamnesis, known intolerance of the respective study medication, current anuresis or acute kidney failure, kidney insufficiency (creatinine clearance < 30 ml/min per 1.73 m² body surface, resp. serum-creatinine > 1.8 mg/dl), known clinically relevant hyperkalaemia or hyponatraemia, known clinically relevant hypotension (RR < 100/80), simultaneous application of potassium-sparing diuretics, ACE inhibitors or AT-II antagonists, NSAR, thiazide-diuretics, carbenoxolon, digoxin, neomycin, lithium. Missing capacity for consent or hospitalisation of patients against their will, insufficient knowledge of the German language, state of treatment resistance or never treated schizophrenia.
研究者
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