Obsessive-Compulsive Disorder
Conditions
Keywords
OCD,, naltrexone,, fluoxetine,, obsessive-compulsive disorder
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.
Interventions
DRUGFluoxetine 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.
DRUGNaltrexone 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.
DRUGNaltrexone 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.
Sponsors
Orexigen Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed