Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

NCT00116532 | Completed Phase 4

• 3 other identifiers: 2002-P-000895LXP-MD-141200-211220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder; Escitalopram; SSRI; Open Label

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Interventions

Escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Forest Laboratories: collaborator

Study Sites (1)

Massachusetts General Hospital - OCD Clinic

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Darin D Dougherty, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2005
• First Posted: June 30, 2005
• Study Start: October 1, 2002
• Study Completion: February 1, 2007
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

US (1)