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Completed

NCT Number: NCT00215137

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

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 names: Lexapro

Placebo ( sugar pill)

Drug

Placebo Comparator in double.blind phase.

Other names: Placebo

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Forest Laboratories

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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