Condition category
Mental and Behavioural Disorders
Date applied
21/03/2010
Date assigned
24/05/2011
Last edited
24/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amcpsychiatrie.nl/

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

Publication citations

Additional files

Editorial Notes