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Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Escitalopram, SSRI, Open Label

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital - OCD Clinic

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
June 29, 2005
Last Updated
April 23, 2007
Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00116532
Brief Title
Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
Official Title
Escitalopram for the Treatment of Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, Escitalopram, SSRI, Open Label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram
Primary Outcome Measure Information:
Title
Y-BOCs scores at 1st and last visit (16 weeks later)
Title
Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)
Secondary Outcome Measure Information:
Title
HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Title
BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Title
BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Title
QLESQ - first and last visit (week 0 and 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darin D Dougherty, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital - OCD Clinic
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

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Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

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