Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

July 27, 2007

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in the somatization subscale of the SCL-90

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00215137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder

Official Title ^ICMJE

Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder

Brief Summary

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

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.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

OCD

Intervention ^ICMJE

Drug: escitalopram

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00215137

Responsible Party

Study ID Numbers ^ICMJE

5731-04-4R0

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Forest Laboratories

Investigators ^ICMJE

Principal Investigator:

Kathryn M. Connor, MD

Duke University

Information Provided By

Duke University

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP