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Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00215137
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : October 29, 2013
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE April 15, 2013
Results First Posted Date  ICMJE October 29, 2013
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE October 2004
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Change in the somatization subscale of the SCL-90
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE OCD
Intervention  ICMJE
  • 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.
    Other Name: Lexapro
  • Drug: Placebo ( sugar pill)
    Placebo Comparator in double.blind phase.
    Other Name: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: escitalopram
  • 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).
    Intervention: Drug: Placebo ( sugar pill)
  • 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).
    Intervention: Drug: escitalopram
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2005)
14
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215137
Other Study ID Numbers  ICMJE Pro00013150
5731-04-4R0 ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Wei M. Zhang, MD, PhD Duke University
PRS Account Duke University
Verification Date August 2013

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