DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Orexigen Therapeutics, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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: Terminated

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.

Clinical Details

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)

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

Primary outcome: 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


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


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

Locations and Contacts

Synergy Clinical Research, National City, California 91950, United States

California Clinical Trials, San Diego, California 92123, United States

University of Florida, Department of Psychiatry, Gainesville, Florida 32606, United States

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States

Indiana University School of Medicine, Indianapolis, Indiana 46202, United States

Global Medical Institute, LLC, Princeton, New Jersey 08540, United States

Brooklyn Medical Institute, Brooklyn, New York 11223, United States

Community Research, Cincinnati, Ohio 45227, United States

Summit Research Network, Inc., Portland, Oregon 97210, United States

Carolina Clinical Research Services, Columbia, South Carolina 29201, United States

Northbrooke Research Center, Brown Deer, Wisconsin 53223, United States

Additional Information

Starting date: September 2008
Last updated: November 27, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017