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Obsessive Compulsive Disorder

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Sponsored by AstraZeneca

About this trial

Last updated 14 years ago

Study ID

D1441C09907

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 19 years ago

What is this trial about?

Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at least three previous treatments with a SRI at maximum dose and duration were assigned to receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is postulated that the combination of a low dose atypical antipsychotic and a standard dosage of an SRI as a treatment for patients with OCD might increase the number of responders as well as the effect size. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

What are the participation requirements?

Yes

Inclusion Criteria

- All patients meet the DSM IV criteria for obsessive-compulsive disorder

- Y-BOCS score > 16 if obsessions and compulsions

- Y-BOCS score > 10 if only obsessions

- Y-BOCS score > 10 if only compulsions

- Male and female, aged between 18-70 years

- Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception.

- Written informed consent

No

Exclusion Criteria

- Presence of any of the following DSM IV conditions; major depression (with a HDRS>15, [17 item]), 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 cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition 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

- Any known contra-indication against citalopram or quetiapine

Locations

Location

Status