Contact information
Type
Scientific
Primary contact
Prof Damiaan Denys
ORCID ID
Contact details
Academic Medical Centre
Psychiatry
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 891 0602
d.denys@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/063
Study information
Scientific title
PRAZosin in combination with a serotonin reuptake Inhibitor for patients with Obsessive Compulsive disorder: an open label 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
Medical Ethics Committee of the Academic Medical Centre Amsterdam in December 2008
Study design
Open label cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
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
Phase
Not Specified
Drug names
Prazosin
Primary outcome measures
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 trial start date
01/03/2010
Overall trial end date
01/08/2010
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
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
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Psychiatry Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 891 3602
m.figee@amc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary