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Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

Phase 3
Completed
Conditions
Obsessive Compulsive Disorder
Registration Number
NCT00254735
Lead Sponsor
AstraZeneca
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Research Site

🇩🇪

Lübeck, Germany

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