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
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escitalopram for the Treatment of Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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)

Estimated Enrollment: 30
Study Start Date: October 2002
Study Completion Date: February 2007
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116532

Locations
United States, Massachusetts
Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Investigators
Principal Investigator: Darin D Dougherty, MD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116532     History of Changes
Other Study ID Numbers: 2002-P-000895, LXP-MD-14, 1200-211220
Study First Received: June 29, 2005
Last Updated: April 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Obsessive Compulsive Disorder
Escitalopram
SSRI
Open Label

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014