Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

OCD Clinical Trial

Official title:

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215137
• Other study ID #: Pro00013150
• Secondary ID: 5731-04-4R0
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: July 14, 2014
• Start date: October 2004
• Est. completion date: March 2009

Study information

• Verified date: August 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder
• OCD

Intervention

Drug:
• escitalopram
Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.
• Placebo ( sugar pill)
Placebo Comparator in double.blind phase.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (1)

C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale	The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.	Open Label Phase Baseline,Randomization Phase Baseline or Beginning	No