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

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)”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Naltrexone SR 32 mg plus fluoxetine 60 mg
• Active Comparator: 2
  • Fluoxetine
• Active Comparator: 3
  • Naltrexone SR 32 mg

Primary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Orexigen Therapeutics, Inc Industry

Overall Clinical Trial Officials and Contacts

Jeffrey T Apter, MD, PA Principal Investigator Global Medical Institutes, LLC  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00758966

Study ID Number: NF-101

ClinicalTrials.gov Identifier: NCT00758966

Health Authority: United States: Food and Drug Administration