Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study - Clinical Trial for Obsessive Compulsive Disorder | NCT00318539

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Quetiapine

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site

Outcomes

Primary Outcome Measures

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

The onset of response to treatment, using the time to a sustained response as criterion

Side effect profiles, Quality of life, Cognitive functioning

Full Information

NCT ID

NCT00318539

First Posted

April 25, 2006

Last Updated

January 20, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00318539

Brief Title

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Primary Outcome Measure Information:

Title

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.

Title

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 Measure Information:

Title

The onset of response to treatment, using the time to a sustained response as criterion

Title

Side effect profiles, Quality of life, Cognitive functioning

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca Netherlands Medical Director, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Utrecht

Country

Netherlands

Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

Obsessive Compulsive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial