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

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Orexigen Therapeutics, Inc

  lead INDUSTRY

Principal Investigators

• Jeffrey T Apter, MD, PA · Global Medical Institutes, LLC

• Ward Smith, MD · Summit Research Network, Inc.

• Vishaal Mehra, MD · California Clinical Trials

• Naresh P Emmanuel, MD · Carolina Clinical Research Services

• Mohammad Bari, MD · Synergy Clinical Research

• Robert Riesenberg, MD · Atlanta Center for Medical Research

• Teresa Pigott, MD · University of Florida, Dept Of Psychiatry

• Andrew W Goddard, MD · Indiana University School of Medicine

• Al Rivera, MD · Community Research

• Jeffrey S Simon, MD · Northbrooke Research Center

• Zinoviy Benzar, MD · Brooklyn Medical Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2008-12-31

Completion

2008-12-31

Countries

• United States

Study Locations