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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Drug: Naltrexone 32 mg and fluoxetine 60 mg; Drug: Fluoxetine 60 mg; Drug: Naltrexone SR 32 mg

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • National City, California, United States, 91950
      • Synergy Clinical Research
    • San Diego, California, United States, 92123
      • California Clinical Trials
  • Florida
    • Gainesville, Florida, United States, 32606
      • University of Florida, Department of Psychiatry
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institute, LLC
  • New York
    • Brooklyn, New York, United States, 11223
      • Brooklyn Medical Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Community Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network, Inc.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Carolina Clinical Research Services
  • Wisconsin
    • Brown Deer, Wisconsin, United States, 53223
      • Northbrooke Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Baseline to Week 10

Collaborators and Investigators

• Sponsor: Orexigen Therapeutics, Inc
• Investigators: Principal Investigator: Zinoviy Benzar, MD, Brooklyn Medical Institute; 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: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; OCD,; naltrexone,; fluoxetine,
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Alcohol Deterrents; Naltrexone; Fluoxetine
• Other Study ID Numbers: NF-101