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Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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, Freiburg, Germany

Research Site, Lübeck, Germany

Additional Information

Starting date: April 2002
Last updated: December 14, 2007

Page last updated: August 23, 2015

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