Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
NCT ID: NCT00758966
Last Updated: 2012-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2008-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NF (Naltrexone+Fluoxetine)
Naltrexone SR 32 mg and fluoxetine 60 mg
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.
Fluoxetine
Fluoxetine 60 mg
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.
Naltrexone
Naltrexone SR 32 mg
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Orexigen Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey T Apter, MD, PA
Role: PRINCIPAL_INVESTIGATOR
Global Medical Institutes, LLC
Ward Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Summit Research Network, Inc.
Vishaal Mehra, MD
Role: PRINCIPAL_INVESTIGATOR
California Clinical Trials
Naresh P Emmanuel, MD
Role: PRINCIPAL_INVESTIGATOR
Carolina Clinical Research Services
Mohammad Bari, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Clinical Research
Robert Riesenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Center for Medical Research
Teresa Pigott, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida, Dept Of Psychiatry
Andrew W Goddard, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Al Rivera, MD
Role: PRINCIPAL_INVESTIGATOR
Community Research
Jeffrey S Simon, MD
Role: PRINCIPAL_INVESTIGATOR
Northbrooke Research Center
Zinoviy Benzar, MD
Role: PRINCIPAL_INVESTIGATOR
Brooklyn Medical Institute
Locations
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Synergy Clinical Research
National City, California, United States
California Clinical Trials
San Diego, California, United States
University of Florida, Department of Psychiatry
Gainesville, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Global Medical Institute, LLC
Princeton, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Community Research
Cincinnati, Ohio, United States
Summit Research Network, Inc.
Portland, Oregon, United States
Carolina Clinical Research Services
Columbia, South Carolina, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Countries
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Other Identifiers
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NF-101
Identifier Type: -
Identifier Source: org_study_id