Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

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 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.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Participants received increasing amounts of Duloxetine for 7 weeks.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; Obsessive Compulsive Disorder; Obsessions; Compulsions; Duloxetine; Cymbalta