Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD) - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Forest Laboratories
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00116532

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 IV

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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

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
Anxiety Disorders
Mental 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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012