Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Obsessive Compulsive Disorder

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318539

D1441C09907

Details and patient eligibility

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

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