Quetiapine Augmentation in Severe Obsessive Compulsive Disorder - Full Text View

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

MedlinePlus related topics:

Obsessive-Compulsive Disorder

ChemIDplus related topics:

Quetiapine Quetiapine fumarate Clomipramine Clomipramine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

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
	Lübeck, Germany
	Research Site
	Freiburg, Germany

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Germany Medical Director, MD	AstraZeneca

More Information

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

Keywords provided by AstraZeneca:

Obsessive Compulsive Disorder (OCD)

Study placed in the following topic categories:

Quetiapine

Anxiety Disorders

Mental Disorders

Clomipramine

Serotonin

Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Antidepressive Agents, Tricyclic

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008

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