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
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.
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
Eligibility
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
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
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