Status:
COMPLETED
Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.
Detailed Description
Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhi...
Eligibility Criteria
Inclusion
- 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
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgment, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular (including hypertension), 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 duloxetine
- Current major depression or prescribed an antidepressant for major depression within the past 12 months. We will assess depressive symptoms with the BDI throughout the course of the study in order to assess subsyndromal depressive symptoms and to assess for the emergence of depressive symptoms.
- Taken other psychotropic 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.
- Known hypersensitivity to duloxetine or any of the inactive ingredients.
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI drug during the study or within 5 days of discontinuation of study drug.
- Patients with uncontrolled narrow-angle glaucoma.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00464698
Start Date
December 1 2005
End Date
December 1 2013
Last Update
March 19 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114