NCT01246908

Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 Modified Release Tablet, 125 mg Twice Per Day in Subjects With Treatment Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: CeNeRx BioPharma Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if CX157 is effective and safe in patients with treatment of treatment resistant depression over six weeks of treatment.

Detailed description

The primary objective of this study is to examine the efficacy of CX157 Modified Release Tablet, 125 mg administered twice per day (BID) as compared to placebo in subjects with Treatment Resistant Depression (TRD). Secondary objectives are to evaluate the safety and tolerability of CX157 Modified Release Tablet, 125 mg BID in TRD subjects and characterize steady-state pharmacokinetic profile and explore pharmacodynamic relationships.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Placebo	Placebo administered twice per day for six weeks.
DRUG	CX157 (TriRima)	One tablet administered twice per day (total daily dose of 250 mg) for six weeks.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-11-24
• Last updated: 2012-07-10

Locations

30 sites across 1 country: United States