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

NCT00758966 | Terminated Phase 2

• 1 other identifier: NF-101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD,; naltrexone,; fluoxetine,; obsessive-compulsive disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

NF (Naltrexone+Fluoxetine)

EXPERIMENTAL

Naltrexone SR 32 mg and fluoxetine 60 mg

Drug: Naltrexone 32 mg and fluoxetine 60 mg

Fluoxetine

ACTIVE COMPARATOR

Fluoxetine 60 mg

Drug: Fluoxetine 60 mg

Naltrexone

ACTIVE COMPARATOR

Naltrexone SR 32 mg

Drug: Naltrexone SR 32 mg

Interventions

Fluoxetine 60 mg DRUG

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.

Fluoxetine

Naltrexone 32 mg and fluoxetine 60 mg DRUG

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.

NF (Naltrexone+Fluoxetine)

Naltrexone SR 32 mg DRUG

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.

Naltrexone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Immediate family of investigators, study personnel or Sponsor representatives

Sponsors & Collaborators

• Orexigen Therapeutics, Inc: lead

Study Sites (11)

Synergy Clinical Research

National City, California, 91950, United States

Location

California Clinical Trials

San Diego, California, 92123, United States

Location

University of Florida, Department of Psychiatry

Gainesville, Florida, 32606, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Global Medical Institute, LLC

Princeton, New Jersey, 08540, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11223, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Summit Research Network, Inc.

Portland, Oregon, 97210, United States

Location

Carolina Clinical Research Services

Columbia, South Carolina, 29201, United States

Location

Northbrooke Research Center

Brown Deer, Wisconsin, 53223, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Fluoxetine; Naltrexone

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

US (11)