Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

This study has been completed.

First Received on November 15, 2005. Last Updated on December 14, 2007 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254735

Purpose

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.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: quetiapine fumarate Drug: SSRI/Clomipramine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Clomipramine hydrochloride Quetiapine Quetiapine fumarate Clomipramine

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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.

Enrollment:	44
Study Start Date:	April 2002
Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254735

Locations

Germany
Research Site
Freiburg, Germany
Research Site
Lübeck, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Germany Medical Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00254735 History of Changes
Other Study ID Numbers:	5077/9059, D1441C09059
Study First Received:	November 15, 2005
Last Updated:	December 14, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Obsessive Compulsive Disorder (OCD)

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Clomipramine
Quetiapine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012