Clinical trial NCT00215137: Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Official title: Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: OCD
Keywords: OCD
SSRI
escitalopram
relapse
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2005-09-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale
timeFrame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei M. Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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