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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

September 22, 2008
November 27, 2012
September 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00758966 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • 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.
  • 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.
  • 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.
  • Experimental: NF (Naltrexone+Fluoxetine)
    Naltrexone SR 32 mg and fluoxetine 60 mg
    Intervention: Drug: Naltrexone 32 mg and fluoxetine 60 mg
  • Active Comparator: Fluoxetine
    Fluoxetine 60 mg
    Intervention: Drug: Fluoxetine 60 mg
  • Active Comparator: Naltrexone
    Naltrexone SR 32 mg
    Intervention: Drug: Naltrexone SR 32 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758966
NF-101
No
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
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
Orexigen Therapeutics, Inc
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP