Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

April 23, 2007 updated by: Massachusetts General Hospital

Escitalopram for the Treatment of Obsessive Compulsive Disorder

The purpose of this study is to assess the efficacy of Escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Purpose: Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. A recent double-blind, placebo-controlled trial demonstrated that citalopram is effective in the treatment of OCD. Escitalopram is a new SSRI that may be more effective than other SSRIs for the treatment of major depression and may have fewer side effects. This study aims to assess the efficacy of escitalopram for the treatment of OCD.

Comparisons: Subject Y-BOCs pre-post treatment. We will also compare the improvement of subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital - OCD Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of OCD by DSM-IV
  • Age 18-65
  • Y-BOCS greater than 20
  • Written informed consent
  • Females of childbearing potential must have a negative serum or urinary beta-HCG test.

Exclusion Criteria:

  • Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
  • Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
  • Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
  • History of seizure disorder
  • Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
  • If there is a history of substance abuse, patients in remission at least 6 months.
  • Currently being treated with behavioral therapy, specifically exposure and response prevention, for OCD.
  • Other medications for medical disorders that may interfere with escitalopram
  • Current major depression or prescribed an antidepressant for major depression within the past 12 months.
  • Taken an SSRI medication within 2 weeks of beginning the study (4 weeks for fluoxetine).
  • More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another SSRI in the past.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Y-BOCs scores at 1st and last visit (16 weeks later)
Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)

Secondary Outcome Measures

Outcome Measure
HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
QLESQ - first and last visit (week 0 and 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Darin D Dougherty, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

June 29, 2005

First Submitted That Met QC Criteria

June 29, 2005

First Posted (Estimate)

June 30, 2005

Study Record Updates

Last Update Posted (Estimate)

April 24, 2007

Last Update Submitted That Met QC Criteria

April 23, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-P-000895
  • LXP-MD-14
  • 1200-211220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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