NCT00758966

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-09-25
• Last updated: 2012-11-29

Locations

11 sites across 1 country: United States