Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00116532
First received: June 29, 2005
Last updated: April 23, 2007
Last verified: April 2007

June 29, 2005
April 23, 2007
October 2002
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00116532 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
Drug: Escitalopram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116532
2002-P-000895, LXP-MD-14, 1200-211220
No
Not Provided
Massachusetts General Hospital
Forest Laboratories
Principal Investigator: Darin D Dougherty, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP