Clonidine added to the current treatment of therapy resistant schizophrenia
- Conditions
- Schizophrenia, schizophreniform disorder, schizoaffective disorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-003008-53-NL
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method