EUCTR2014-003008-53-NL进行中(未招募)不适用
Clonidine Augmentation Therapy in Schizophrenia - CATS (Clonidine Augmentation Therapy in Schizophrenia)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 75
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. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or
- •schizoaffective disorder)
- •2. No or only partial response to clozapine as defined by a total PANSS score of at least 80.
- •3. Age 18-45 years.
- •4. Patients are treated with antipsychotic medication
- •5. Written informed consent
- •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 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of any of the contra-indications of clonidine as reported in the Summary of Product Characteristics (SPC).
- •2. Supine systolic blood pressure (SSBP) < 85 mm HG
- •3. Pre-existent orthostatic hypotension with a drop of systolic blood pressure of > 20 mmHg or a drop of diastolic blood pressure of >10 mmHg.
- •4. Supine heart rate (SHR) < 50 beats/min
- •5. Severe brady-arhytmias such as sick-sinussyndroom, second or third degree AV-block.
- •6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening.
研究者
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