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

Condition(s) targeted: Obsessive-Compulsive Disorder

Intervention: Fluoxetine 60 mg (Drug); Naltrexone 32 mg and fluoxetine 60 mg (Drug); Naltrexone SR 32 mg (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Orexigen Therapeutics, Inc

Official(s) and/or principal investigator(s):
Jeffrey T Apter, MD, PA, Principal Investigator, Affiliation: Global Medical Institutes, LLC
Ward Smith, MD, Principal Investigator, Affiliation: Summit Research Network, Inc.
Vishaal Mehra, MD, Principal Investigator, Affiliation: California Clinical Trials
Naresh P Emmanuel, MD, Principal Investigator, Affiliation: Carolina Clinical Research Services
Mohammad Bari, MD, Principal Investigator, Affiliation: Synergy Clinical Research
Robert Riesenberg, MD, Principal Investigator, Affiliation: Atlanta Center for Medical Research
Teresa Pigott, MD, Principal Investigator, Affiliation: University of Florida, Dept Of Psychiatry
Andrew W Goddard, MD, Principal Investigator, Affiliation: Indiana University School of Medicine
Al Rivera, MD, Principal Investigator, Affiliation: Community Research
Jeffrey S Simon, MD, Principal Investigator, Affiliation: Northbrooke Research Center
Zinoviy Benzar, MD, Principal Investigator, Affiliation: Brooklyn Medical Institute

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome: Evaluate the mean change from baseline to Week 10 in total Y-BOCS score between the combination treatment group versus fluoxetine alone and naltrexone SR alone

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

California Clinical Trials, San Diego, California 92123, United States; Recruiting
Karen Farella, Phone: 858-571-1188, Email: karen.farella@cctrials.com
Marie Delguidice, Phone: 800.571.1188, Email: marie.delguidice@cctrials.com
Vishaal Mehra, MD, Principal Investigator

Synergy Clinical Research, National City, California 91950, United States; Recruiting
Christine Delgado, Phone: 619-327-0155, Ext: 117, Email: delgadoc@synergysandiego.com
Mohammed Bari, MD, Principal Investigator

University of Florida, Department of Psychiatry, Gainesville, Florida 32606, United States; Not yet recruiting
Jane Lu, Phone: 877-788-3994, Email: trials@psychiatry.ufl.edu
Teresa Pigott, Principal Investigator

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States; Recruiting
Zack Cates, Phone: 404-881-5800, Email: zcates@acmr.org
Robert Riesenberg, MD, Principal Investigator

Indiana University School of Medicine, Indianapolis, Indiana 46202, United States; Not yet recruiting
Carla Medlock, Phone: 317-274-0314, Email: cemedloc@iupui.edu
Andrew W Goddard, MD, Principal Investigator

Global Medical Institute, LLC, Princeton, New Jersey 08540, United States; Recruiting
Ted Wolfson, Phone: 609-921-3555, Ext: 28, Email: twolfson@gminstitutes.com
Jeffrey T Apter, MD, Principal Investigator

Brooklyn Medical Institute, Brooklyn, New York 11223, United States; Recruiting
Polina Sadkovets, Phone: 718-339-7711, Email: psadkovets@gminstitutes.com
Zinoviy Benzar, MD, Principal Investigator

Community Research, Cincinnati, Ohio 45227, United States; Recruiting
Adam Rothstein, Phone: 513-721-3866, Ext: 158, Email: arothstein@communityresearch.com
Al Rivera, MD, Principal Investigator

Summit Research Network, Inc., Portland, Oregon 97210, United States; Not yet recruiting
Annika Truitt, Phone: 503-972-9822, Email: atruitt@summitnetwork.com
Ward Smith, MD, Principal Investigator

Carolina Clinical Research Services, Columbia, South Carolina 29201, United States; Recruiting
Naresh Emmanuel, Phone: 803-988-0091, Email: nemmanuel@ccrsclinicaltrials.com
Naresh Emmanuel, MD, Principal Investigator

Northbrooke Research Center, Brown Deer, Wisconsin 53223, United States; Recruiting
Molly Simon, Phone: 414-357-9444, Email: mollymsimon@aol.com
Jeffrey S Simon, MD, Principal Investigator

Starting date: September 2008
Ending date: November 2009
Last updated: September 23, 2008