Addition of Quetiapine in Obsessive Compulsive Disorder -... | NCT00318539

Studies
Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study

NCT00318539

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 21, 2011Estimated

Enrollment

Phase

Phase 2

Conditions

Obsessive Compulsive Disorder

Interventions

Quetiapine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Apr 25, 2006

First Submission Date that Met QC Criteria

Apr 25, 2006

First Posted Date

Apr 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2011

Last Update Posted Date

Jan 21, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Quetiapine	Drug

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds