Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

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.

Interventions

  • 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.
  • Drug: Placebo ( sugar pill)
    • Placebo Comparator in double.blind phase.

Arms, Groups and Cohorts

  • Experimental: Open Label Escitalopram 10-20 mg/daily
    • Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
  • Placebo Comparator: Randomizationn Placebo 10-20 mg daily
    • Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
  • Active Comparator: Randomization Escitalopram 10-20 mg/daily
    • Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).

Clinical Trial Outcome Measures

Primary Measures

  • Yale Brown Obsessive Compulsive Scale
    • Time Frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning
    • 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • Forest Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wei M. Zhang, MD, PhD, Principal Investigator, Duke University

Citations Reporting on Results

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

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