Clinical trial NCT00758966: 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 Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD,
naltrexone,
fluoxetine,
obsessive-compulsive disorder
Lead sponsor: Orexigen Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: Baseline to Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: San Diego
country: United States
facility: California Clinical Trials
state: California
city: Gainesville
country: United States
facility: University of Florida, Department of Psychiatry
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Princeton
country: United States
facility: Global Medical Institute, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Portland
country: United States
facility: Summit Research Network, Inc.
state: Oregon
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
Study officials:
affiliation: Global Medical Institutes, LLC
name: Jeffrey T Apter, MD, PA
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Research Network, Inc.
name: Ward Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Clinical Trials
name: Vishaal Mehra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Clinical Research Services
name: Naresh P Emmanuel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synergy Clinical Research
name: Mohammad Bari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Center for Medical Research
name: Robert Riesenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida, Dept Of Psychiatry
name: Teresa Pigott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Andrew W Goddard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: Al Rivera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northbrooke Research Center
name: Jeffrey S Simon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooklyn Medical Institute
name: Zinoviy Benzar, MD
role: PRINCIPAL_INVESTIGATOR
References: