Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD) (FIJ-MC-1003)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00464698|
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Duloxetine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duloxetine for the Treatment of Obsessive Compulsive Disorder|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: All Study Participants
Duloxetine 30mg: Dose level 1 (Week 1) Duloxetine 60mg: Dose level 2 (Wks 2-4) Duloxetine 120mg: Dose level 3 (Wks 3-7)
Participants received increasing amounts of Duloxetine for 7 weeks.
Other Name: Cymbalta
- Y-BOCS Scores at 1st and Last Visit [ Time Frame: Week 0 to 17 ]OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.
- BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17). [ Time Frame: Week 0 to 17 ]
Depression severity, such that higher scores on the BDI are reflective of more severe depression.
BDI minimum score: 0 MDI maximum score: 63
- BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17) [ Time Frame: Week 0 to 17 ]
Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.
Minimum value: 0 Maximum value: 63
- QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17) [ Time Frame: Week 0 to 17 ]
Quality of life, such that lower score reflects poorer quality of life
Minimum score: 16 Maximum score: 80
- Clinical Global Impressions Scale at Week 3 and Week 17 [ Time Frame: Week 3 to 17 ]
Global severity of illness, such that a higher score reflects worse global severity
Minimum score: 2 Maximum score: 14
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464698
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Darin D Dougherty, MD||Massachusetts General Hospital|