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

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Fluoxetine 60 mg
* Drug: Naltrexone 32 mg and fluoxetine 60 mg
* Drug: Naltrexone SR 32 mg


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NF (Naltrexone+Fluoxetine)<br>Naltrexone SR 32 mg and fluoxetine 60 mg | Drug: Naltrexone 32 mg and fluoxetine 60 mg<br>* 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.<br>|
| Active Comparator: Fluoxetine<br>Fluoxetine 60 mg | Drug: Fluoxetine 60 mg<br>* 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.<br>|
| Active Comparator: Naltrexone<br>Naltrexone SR 32 mg | Drug: Naltrexone SR 32 mg<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder