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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00464698 |
Purpose
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: Duloxetine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Duloxetine for the Treatment of Obsessive Compulsive Disorder |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors (SNRIs), and behavioral therapy. Duloxetine is a new SNRI. This study aims to assess the efficacy of duloxetine for the treatment of OCD.
Before subjects give written informed consent, they are made aware of alternatives to participation in this study, which can include independently seeking pharmacotherapy or cognitive behavioral treatment for OCD. Patients will then begin open-label treatment with duloxetine at 30 mg/day and will be seen again in one week (Visit 2). At Visit 2, patients will be assessed and, if they are not experiencing any significant side effects, the dose will be increased to 60 mg/day. Patients who are experiencing significant side effects at 30 mg/day will be discontinued from the study and offered standard treatment in our clinic. Patients taking 60 mg/day will then return for assessment in four weeks (Visit 3). At this time, if they are not experiencing any significant side effects, the dose will then be increased to 120 mg/day. Patients who are unable to tolerate 120 mg/day will have their dose decreased back down to 60 mg/day and will continue the trial. End of study final statistical analyses will be conducted both including and excluding these patients. Remaining assessments will be every 4 weeks (Visits 4, 5, 6). Thus, in total this is a 17-week study with 12 weeks at the high dose believed to be necessary for response.
At each visit following the initial visit, patients will be assessed using the Y-BOCS, BDI, BAI, and CGI. The Q-LES-Q will only be administered at the initial and last visit.
The study procedure is similar to standard medical treatment for OCD at MGH. Like standard care, participants start on the lowest dose of the medication and then increase that dose to the maximally tolerated level. Barring any significant side effects, the patient remains on that dose for 4-8 weeks to provide the medication with an adequate trial period. At the end of that period, efficacy would be assessed and other alternatives would be discussed.
One difference between the study and standard care is that the study will provide more assessment through verbal and written scales. This additional assessment could greatly benefit the patient as they decide between other treatment options. Another difference is that participants cannot be involved in current behavior therapy throughout the study. Many patients choose to pursue medical treatment without behavior therapy in standard care; however, in standard care, they have the option of pursuing both concurrently or pursuing just behavior therapy. If a patient wishes to pursue just behavior therapy or receive medication and therapy concurrently, then other forms of treatment at MGH might be more appropriate. If they only want medical treatment, the study is similar to standard care at a lower cost.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tina Chou, BA | 617-643-5129 | tchou@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Sub-Investigator: Nancy J Keuthen, PhD | |
| Sub-Investigator: Michael Jenike, MD | |
| Principal Investigator: | Darin D Dougherty, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Darin Dougherty, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00464698 History of Changes |
| Other Study ID Numbers: | 2005-P-002159, FIJ-MC-1003 |
| Study First Received: | April 23, 2007 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
OCD Obsessive Compulsive Disorder Obsessions |
Compulsions Duloxetine Cymbalta |
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents |
Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |