Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Yale Brown obsessive compulsive scale (Y-BOCS) from baseline to week 10 and the number of responders are the primary efficacy parameters. |  |  | 
| Criteria for response will be a 25% or greater change from baseline on the Y-BOCS and a final CGI rating of much improved or very much improved. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of response to treatment, using the time to a sustained response as criterion |  |  | 
| Side effect profiles, Quality of life, Cognitive functioning |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive Compulsive Disorder