Back to resultsQuetiapine Augmentation in Severe Obsessive Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
quetiapine fumarate
SSRI/Clomipramine
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder (OCD)
Eligibility Criteria
Inclusion Criteria: Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine Exclusion Criteria: Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary Outcome Measures
Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254735
Brief Title
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
Official Title
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.
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 (OCD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
SSRI/Clomipramine
Primary Outcome Measure Information:
Title
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary Outcome Measure Information:
Title
Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Title
Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine
Exclusion Criteria:
Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Germany Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Lübeck
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
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