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| [ ...Back to search results ] | [ Print-friendly version ] |
| PRAZosin for patients with Obsessive Compulsive disorder |
| ISRCTN | ISRCTN61562706 |
| ClinicalTrials.gov identifier | |
| Public title | PRAZosin for patients with Obsessive Compulsive disorder |
| Scientific title | PRAZosin in combination with a serotonin reuptake Inhibitor for patients with Obsessive Compulsive disorder: an open label study |
| Acronym | PRAZOC |
| Serial number at source | 08/063 |
| Study hypothesis | It is hypothesised that prazosin in combination with a Serotonin Reuptake Inhibitor (SRI) might possess an anti-obsessive compulsive disorder (OCD) modulating effect by raising dopamine (DA) levels in the synaptic cleft in the prefrontal cortex and inhibiting extracellular DA concentrations in the nucleus accumbens |
| Lay summary | |
| Ethics approval | Medical Ethics Committee of the Academic Medical Centre Amsterdam in December 2008 |
| Study design | Open label cohort study |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Obsessive compulsive disorder |
| Participants - inclusion criteria |
1. All patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for obsessive-compulsive disorder
2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score (two consecutive measurements within two weeks) 2.1. > 16 if obsessions and compulsions 2.2. > 10 if only obsessions 2.3. > 10 if only compulsions 3. Therapy resistance, defined as not having responded to at least 1 previous treatment with an SRI at maximum dose and duration 4. Male and female, aged between 18-70 years 5. Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception 6. Written informed consent |
| Participants - exclusion criteria |
1. Presence of any of the following DSM IV conditions:
1.1. Major depression (with a Hamilton Depression Rating Scale [HDRS] > 15, [17 item]) 1.2. Bipolar disorder 1.3. Schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months 1.4. Epilepsy 1.5. Structural central nervous system (CNS) disorder or stroke within the last year 2. Evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition abnormalities 3. Patients at risk for suicide 4. Multiple serious drug allergies or known allergy for the trial compounds 5. Use of antipsychotics during 6 months before the screening visit 6. Use of any other psychotropic drug during 6 months before the screening visit 7. Cognitive and behavioural treatment 3 months prior to the screening visit 8. Use of drugs that interact with prazosin: diuretic or other antihypertensive agents ( which can cause an additive hypotensive effect) 9. Regular use of alcohol |
| Anticipated start date | 01/03/2010 |
| Anticipated end date | 01/08/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 10 |
| Interventions |
1. Prazosin 5-20 mg/day for 12 weeks in addition to ongoing treatment with SRI
2. The total duration of follow up will be 12 weeks (i.e. no follow up beyond the end of the intervention) |
| Primary outcome measure(s) |
1. Decrease in Y-BOCS score
2. Measured at baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Secondary outcome measure(s) |
1. Clinical Global Impression (CGI)
2. Hamilton Depression Rating Scale (HDRS) 3. All outcomes measured at baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Sources of funding | Academic Medical Centre (AMC) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Prof Damiaan Denys |
| Address |
Academic Medical Centre
Psychiatry Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 891 0602 |
| d.denys@amc.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Psychiatry Department
Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 891 3602 |
| Fax | +31 (0)20 891 3702 |
| m.figee@amc.nl | |
| Sponsor website: | http://www.amcpsychiatrie.nl/ |
| Date applied | 21/03/2010 |
| Last edited | 24/05/2011 |
| Date ISRCTN assigned | 24/05/2011 |
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