NCT00448292

A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Epix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.

Detailed description

Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	PRX-00023	Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
DRUG	Placebo for PRX-00023	Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

Timeline

• Start date: 2007-03-01
• Completion: 2007-11-01
• First posted: 2007-03-16
• Last updated: 2007-11-14

Locations

21 sites across 1 country: United States