Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

NCT00464698 | Completed Phase 4 Results DMC

• 2 other identifiers: 2005-P-002159FIJ-MC-1003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; Obsessive Compulsive Disorder; Obsessions; Compulsions; Duloxetine; Cymbalta

Outcome Measures

Primary Outcomes (1)

• Y-BOCS Scores at 1st and Last Visit

  OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.

  Week 0 to 17

Secondary Outcomes (4)

• BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).

  Week 0 to 17

• BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)

  Week 0 to 17

• QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)

  Week 0 to 17

• Clinical Global Impressions Scale at Week 3 and Week 17

  Week 3 to 17

Study Arms (1)

All Study Participants

EXPERIMENTAL

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

Interventions

Duloxetine DRUG

Participants received increasing amounts of Duloxetine for 7 weeks.

Also known as: Cymbalta

All Study Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Dougherty DD, Corse AK, Chou T, Duffy A, Arulpragasam AR, Deckersbach T, Jenike MA, Keuthen NJ. Open-label study of duloxetine for the treatment of obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2015 Jan 30;18(2):pyu062. doi: 10.1093/ijnp/pyu062. Print 2015.

  PMID: 25637377 DERIVED

Related Links

• PubMed

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Obsessive Behavior; Compulsive Behavior

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Darin D. Dougherty, MD
• Organization: Massachusetts General Hospital

ddougherty@partners.org

617-724-6300

Study Officials

• Darin D Dougherty, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: December 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 19, 2019
• Results First Posted: March 7, 2017

Record last verified: 2019-03

Locations

US (1)