Phase 4 N=20 Treatment

Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00464698 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Y-BOCS Scores at 1st and Last Visit — 27.45; 20.45 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Duloxetine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Y-BOCS Scores at 1st and Last Visit	27.45; 20.45	—
SECONDARY BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).	10.30; 6.95	—
SECONDARY BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)	10.70; 6.75	—
SECONDARY QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)	70.14; 74.55	—
SECONDARY Clinical Global Impressions Scale at Week 3 and Week 17	4.0; 2.70	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00464698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.