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

Phase 2

Terminated

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Naltrexone SR 32 mg; Drug: Naltrexone 32 mg and fluoxetine 60 mg; Drug: Fluoxetine 60 mg

• Registration Number: NCT00758966
• Lead Sponsor: Orexigen Therapeutics, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	Naltrexone SR 32 mg	Naltrexone SR 32 mg
NF (Naltrexone+Fluoxetine)	Naltrexone 32 mg and fluoxetine 60 mg	Naltrexone SR 32 mg and fluoxetine 60 mg
Fluoxetine	Fluoxetine 60 mg	Fluoxetine 60 mg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Northbrooke Research Center; 🇺🇸 Brown Deer, Wisconsin, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Carolina Clinical Research Services; 🇺🇸 Columbia, South Carolina, United States

Global Medical Institute, LLC; 🇺🇸 Princeton, New Jersey, United States

Summit Research Network, Inc.; 🇺🇸 Portland, Oregon, United States

Brooklyn Medical Institute; 🇺🇸 Brooklyn, New York, United States

University of Florida, Department of Psychiatry; 🇺🇸 Gainesville, Florida, United States

Synergy Clinical Research; 🇺🇸 National City, California, United States

California Clinical Trials; 🇺🇸 San Diego, California, United States

Community Research; 🇺🇸 Cincinnati, Ohio, United States