Obsessive Compulsive Disorder | Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
Obsessive Compulsive Disorder research study
What is the primary objective of this study?
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.
Who is eligible to participate?
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 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Obsessive Compulsive Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DuloxetineParticipants received increasing amounts of Duloxetine for 7 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
All Study ParticipantsDuloxetine 30mg: Dose level 1 (Week 1) Duloxetine 60mg: Dose level 2 (Wks 2-4) Duloxetine 120mg: Dose level 3 (Wks 3-7)
Start Date: December 2005
Completed Date: December 2013
Phase: Phase 4
Primary Outcome: Y-BOCS Scores at 1st and Last Visit
Secondary Outcome: BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).
Study sponsors, principal investigator, and references
Principal Investigator: Darin D Dougherty, MD
Lead Sponsor: Massachusetts General Hospital
Collaborator: Eli Lilly and Company