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

Stopped early · Phase 2

Conditions studied: Obsessive-Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT00758966

Run by

Orexigen Therapeutics, Inc

People needed

8

Starts

2008-09-01

Expected to finish

2008-12-01

Last updated by the study team

2012-11-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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