Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder Clinical Trial

Official title:

Escitalopram for the Treatment of Obsessive Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116532
• Other study ID #: 2002-P-000895
• Secondary ID: LXP-MD-141200-21
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2005
• Last updated: April 23, 2007
• Start date: October 2002
• Est. completion date: February 2007

Study information

• Verified date: April 2007
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
United States	Massachusetts General Hospital - OCD Clinic	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Y-BOCs scores at 1st and last visit (16 weeks later)
Primary	Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)
Secondary	HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Secondary	BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Secondary	BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
Secondary	QLESQ - first and last visit (week 0 and 16)