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

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orexigen Therapeutics, Inc
• Treatments: Fluoxetine; Naltrexone

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