To determine whether the addition of the *1 adrenoreceptor antagonist prazosin to SSRI is useful for patients with OCD who do not respond to SRI monotherapy.
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in Yale Brown obsessive-compulsive scale (Y-BOCS) and the number of
responders (at least 25% change on the Y-BOCS and final CGI rating of *much
improved* or *very much improved for two consecutive times).
Secondary outcome
Changes on following rating scales:
CGI: clinical global impression scale
BABS: Brown assessment of beliefs scale
HDRS: Hamilton depression rating scale
HAS: Hamilton anxiety rating scale
PADUA INVENTORY: measuring the degree of distress causes by OC symptoms
SPQ: measuring the degree of schizotypic personality
SEEHAN DISABILITY SCALES (SDS): measures functional impairment in three domains
(social, family and work)
Background summary
The neurotransmitter serotonin has been implicated in the pathophysiology of
OCD. However, 40% to 60% of the patients remain unimproved after treatment with
serotonin re uptake inhibitors (SRIs).
Prazosin is a central nervous system active *1 adrenoreceptor antagonist and
has been registered as an anti-hypertensive agent.
Given the (1) involvement of the dopaminergic system in OCD, (2) in vitro
findings of dopaminergic neuro-modulation by prazosin in limbic-striatal and
cortical structures, and (3) the efficacy of prazosin in anxiety disorders
(PTSD), we hypothesize a beneficial effect of prazosin addition to SRIs in OCD
patients.
Study objective
To determine whether the addition of the *1 adrenoreceptor antagonist prazosin
to SSRI is useful for patients with OCD who do not respond to SRI monotherapy.
Study design
The trial will have an open-label design with a fixed dose regimen, with
prazosin being added to ongoing SRI treatment.
Intervention
Prazosin will be administered at the maximum tolerable dosage in addition to an
SRI for 12 weeks.
Study burden and risks
There are no serious risks associated with this study, aside from transient
side-effects. Immediate advantage can be expected because of the potential
therapeutic effect in this severe and therapie-resistent type of OCD. Also, the
results can offer insight into the pathophysiology of OCD and may lead to
future development of more effective medication.
Meibergdreef 5
1105 BC Amsterdam
NL
Meibergdreef 5
1105 BC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
DSM IV diagnosis obsessive-compulsive disorder
Y-BOCS score > 16
Therapy resistance (no response to at least 1 previous SRI treatment)
Male and female, aged 18-70 years
negative pregnancy test
Written informed consent
Exclusion criteria
Presence of major depression (HDRS>15), bipolar disorder, schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months, epilepsy, or any structural CNS disorder or stroke within the last year.
Evidence of clinically significant and unstable somatic abnormalities.
Patients at risk for suicide
Multiple serious drug allergies or known allergy for the trial compounds
Use of antipsychotics during 6 months before the screening visit
Use of any other psychotropic drug during 6 months before the screening visit
Cognitive and behavioural treatment 3 months prior to the screening visit
Use of drugs that interact with prazosin: diuretic, other antihypertensive agents, regular use of alcohol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001017-14-NL |
| CCMO | NL21739.018.08 |