Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Darin D Dougherty, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Escitalopram for the Treatment of Obsessive Compulsive Disorder
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Massachusetts General Hospital - OCD Clinic, Charlestown, Massachusetts 02129, United States
Additional Information
Starting date: October 2002
Ending date: February 2007
Last updated: April 23, 2007
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