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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. Identifier: NCT00464698
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : March 7, 2017
Last Update Posted : March 19, 2019
Eli Lilly and Company
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Duloxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)
Drug: Duloxetine
Participants received increasing amounts of Duloxetine for 7 weeks.
Other Name: Cymbalta

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00464698

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Eli Lilly and Company
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Principal Investigator: Darin D Dougherty, MD Massachusetts General Hospital
Additional Information:
PubMed  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Darin Dougherty, Principal Investigator, Massachusetts General Hospital Identifier: NCT00464698    
Other Study ID Numbers: 2005-P-002159
First Posted: April 24, 2007    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Darin Dougherty, Massachusetts General Hospital:
Obsessive Compulsive Disorder
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents