Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: quetiapine fumarate (Drug); SSRI/Clomipramine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Germany Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Lübeck, Germany
Research Site, Freiburg, Germany
Additional Information
Starting date: April 2002
Ending date: March 2006
Last updated: December 14, 2007
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