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

This study has been terminated.
(Sponsor Decision- Financial Considerations)
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00758966
First received: September 22, 2008
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
 Drug: Fluoxetine 60 mg
Drug: Naltrexone 32 mg and fluoxetine 60 mg
Drug: Naltrexone SR 32 mg
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NF (Naltrexone+Fluoxetine)
Naltrexone SR 32 mg and fluoxetine 60 mg
 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.
Active Comparator: Fluoxetine
Fluoxetine 60 mg
 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.
Active Comparator: Naltrexone
Naltrexone SR 32 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758966

Locations
United States, California
Synergy Clinical Research
National City, California, United States, 91950
California Clinical Trials
San Diego, California, United States, 92123
United States, Florida
University of Florida, Department of Psychiatry
Gainesville, Florida, United States, 32606
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Global Medical Institute, LLC
Princeton, New Jersey, United States, 08540
United States, New York
Brooklyn Medical Institute
Brooklyn, New York, United States, 11223
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45227
United States, Oregon
Summit Research Network, Inc.
Portland, Oregon, United States, 97210
United States, South Carolina
Carolina Clinical Research Services
Columbia, South Carolina, United States, 29201
United States, Wisconsin
Northbrooke Research Center
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Jeffrey T Apter, MD, PA Global Medical Institutes, LLC
Principal Investigator: Ward Smith, MD Summit Research Network, Inc.
Principal Investigator: Vishaal Mehra, MD California Clinical Trials
Principal Investigator: Naresh P Emmanuel, MD Carolina Clinical Research Services
Principal Investigator: Mohammad Bari, MD Synergy Clinical Research
Principal Investigator: Robert Riesenberg, MD Atlanta Center for Medical Research
Principal Investigator: Teresa Pigott, MD University of Florida, Dept Of Psychiatry
Principal Investigator: Andrew W Goddard, MD Indiana University School of Medicine
Principal Investigator: Al Rivera, MD Community Research
Principal Investigator: Jeffrey S Simon, MD Northbrooke Research Center
Principal Investigator: Zinoviy Benzar, MD Brooklyn Medical Institute
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00758966     History of Changes
Other Study ID Numbers: NF-101
Study First Received: September 22, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
OCD,
naltrexone,
fluoxetine,
obsessive-compulsive disorder

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Naltrexone
Fluoxetine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 13, 2013