PRAZosin for patients with Obsessive Compulsive disorder

Not Applicable

Completed

• Conditions: Obsessive compulsive disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN61562706
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

2016 results in https://pubmed.ncbi.nlm.nih.gov/26712326/ (added 29/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-08-01
• Study Start: 2011-05-24
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Decrease in Y-BOCS score<br> 2. Measured at baseline, 2, 4, 6, 8, 10 and 12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical Global Impression (CGI)<br> 2. Hamilton Depression Rating Scale (HDRS)<br> 3. All outcomes measured at baseline, 2, 4, 6, 8, 10 and 12 weeks<br>