PRAZosin for patients with Obsessive Compulsive disorder
| ISRCTN | ISRCTN61562706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61562706 |
| Secondary identifying numbers | 08/063 |
- Submission date
- 21/03/2010
- Registration date
- 24/05/2011
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Damiaan Denys
Scientific
Scientific
Academic Medical Centre
Psychiatry
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 891 0602 |
|---|---|
| d.denys@amc.nl |
Study information
| Study design | Open label cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | PRAZosin in combination with a serotonin reuptake Inhibitor for patients with Obsessive Compulsive disorder: an open label study |
| Study acronym | PRAZOC |
| 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 |
| Ethics approval(s) | Medical Ethics Committee of the Academic Medical Centre Amsterdam in December 2008 |
| Condition | Obsessive compulsive disorder |
| Intervention | 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) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prazosin |
| Primary outcome measure | 1. Decrease in Y-BOCS score 2. Measured at baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Secondary outcome measures | 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 |
| Overall study start date | 01/03/2010 |
| Overall study end date | 01/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 10 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/03/2010 |
| Recruitment end date | 01/08/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Psychiatry Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 891 3602 |
|---|---|
| m.figee@amc.nl | |
| Website | http://www.amcpsychiatrie.nl/ |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: Publication reference added.
