Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
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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 |
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 May 22, 2013