Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder - Full Text View

Sponsor:	Duke University
Collaborator:	Forest Laboratories
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00215137

Purpose

This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

Condition	Intervention	Phase
OCD	Drug: escitalopram	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Change in the somatization subscale of the SCL-90

Secondary Outcome Measures:

YBOCS total and subscale scores
SCL-90 total and subscale scores
HADS subscale scores
CGI-S
CGI-I
SDS total and subscale scores
occurrence of adverse events

Estimated Enrollment:	14
Study Start Date:	October 2004

Detailed Description:

OCD is a chornic and disabling disorder for which SSRI drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.

This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of OCD
A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

Exclusion Criteria:

Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
A primary diagnosis of another Axis I psychiatric disorder
Alcohol or other substance abuse or dependence within the last 6 months
Unstable medical condition
Clinically significant laboratory abnormality
Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day
Active suicidality
History of violent behavior in the past year or current risk of serious violence
A history of sensitivity to citalopram or escitalopram
Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)
Need for concurrent psychotherapeutic intervention
Pregnant or lactating females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215137

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Forest Laboratories

Investigators

Principal Investigator:

Kathryn M. Connor, MD

Duke University

More Information

No publications provided

Study ID Numbers:	5731-04-4R0
Study First Received:	September 20, 2005
Last Updated:	July 27, 2007
ClinicalTrials.gov Identifier:	NCT00215137 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Duke University:

OCD
SSRI
escitalopram
relapse

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Obsessive-Compulsive Disorder
Antidepressive Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010