Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

A Proof-of-Concept, Multicenter, Randomized, Double-Blind, Parallel Study of Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758966
• Other study ID #: NF-101
• Status: Terminated
• Phase: Phase 2
• First received: September 22, 2008
• Last updated: November 27, 2012
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Orexigen Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female subjects, 18 to 60 years of age (inclusive)

• Outpatients with a current diagnosis of OCD that have received previous therapy

• Negative serum pregnancy test as screening in women of child-bearing potential

• If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception

• No clinically significant abnormality on electrocardiogram (ECG)

• No clinically significant laboratory abnormality at screening

• Negative urine drug screen

• Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule

Exclusion Criteria:

• Diagnosis of substance dependence

• Diagnosis of substance abuse (except for nicotine and caffeine)

• Serious or unstable medical illnesses

• Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder

• Diagnosis of tic disorder or Tourette's Syndrome

• Subjects diagnosed with impulse control disorder

• Known sensitivity or allergic reaction to either naltrexone or fluoxetine

• Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study

• Immediate family of investigators, study personnel or Sponsor representatives

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Fluoxetine 60 mg
Two week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy.
• Naltrexone 32 mg and fluoxetine 60 mg
Two week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg.
• Naltrexone SR 32 mg
Two week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Community Research	Cincinnati	Ohio
United States	Carolina Clinical Research Services	Columbia	South Carolina
United States	University of Florida, Department of Psychiatry	Gainesville	Florida
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Synergy Clinical Research	National City	California
United States	Summit Research Network, Inc.	Portland	Oregon
United States	Global Medical Institute, LLC	Princeton	New Jersey
United States	California Clinical Trials	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone		Baseline to Week 10	No