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

Sponsor:	Orexigen Therapeutics, Inc
Information provided by:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00758966

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 II

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 Naltrexoe Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Naltrexone Naltrexone hydrochloride Fluoxetine Fluoxetine hydrochloride

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 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: 1 Naltrexone SR 32 mg plus 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: 2 Fluoxetine	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: 3 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:	Dr. Ronald Landbloom/Vice President or Regulatory and Medical Affairs, Orexigen Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00758966 History of Changes
Other Study ID Numbers:	NF-101
Study First Received:	September 22, 2008
Last Updated:	February 4, 2010
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
Anxiety Disorders
Mental 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 February 09, 2012