Clonidine Augmentation Treatment in Schizophrenia - CATS-Study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 75 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. A DSM-IV-R diagnosis of: 295.x (schizophrenia), schizophreniform disorder, or schizoaffective disorder)
•3. A total PANSS score of at least 55
•4. Age 18-50 years.
•5. Patients are treated with antipsychotic medication
•6. Written informed consent
•7. Female patients of childbearing potential need to utilize a proper method of contraception
•8. (oral anticonceptives, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm) in case of sexual intercourse during the study.
•Ad. A priority will be given to patients who achieve no or only partial response to clozapine as defined by a total PANSS score of at least 80.;Inclusion criteria healthy controls:
•-Age between 18-50 years
•-Good Physical and Mental Health meeting criteria never mentally ill, which will be evaluated with a medical history checklist;
•-Age between 18 and 45 years;
•-Written informed consent of the subject.

•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.
•7. The use of drugs that affect the (nor)adrenergic system such as beta-blockes and mirtazapine.;Exclusion criteria healthy controls:
•-Current use of any medication prescribed medication exclusive oral anticonceptives;
•-Any subject who has received any investigational medication within 30 days prior to the start of this study;
•-History of neurologic illness; History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria;
•-History of alcohol and drug abuse;
•-BMI below 18.5.

发起方

niversitair Medisch Centrum Utrecht