EUCTR2014-001968-35-DE进行中（未招募）1 期
Add-on spironolactone for the treatment of schizophrenia - SPIROTREAT
Klinikum der Universität München - AöR vertreten durch den Vorstand des Bereiches umanmedizinH0 个研究点目标入组 90 人开始时间: 2015年1月23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
- 90
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
- •Essential inclusion Criteria:
- •Male and female patients with schizophrenia (ICD-10 Criteria), no longer in acute phase of illness (PANSS Total = 75, CGI = 4), duration of illness > 6 months, age between 18 and 65 years
- •Have need for a combination treatment with a maximum of 2 antipsychotics. Excluded antipsychotics can be found under 4.3.
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Essential exclusion Criteria:
- •Female Patients: Pregnancy, no medically-approved methods of 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 exclusively a renal eliminable compound (amisulprid), planned 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 (only for additional examination TMS with separate Informed Consent Form), 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.
- •Known clinical need for antipsychotic combination treatment with more than two antipsychotics.
研究者
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