Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

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.

Conditions

• Treatment Resistant Depression

Interventions

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.

Sponsors & Collaborators

• CeNeRx BioPharma Inc.

  lead INDUSTRY

Principal Investigators

• Alan Yeo, MD · Summitt Research Network - Oregon

• Ram Shrivastava, MD · Eastside Comprehensive Medical Center

• Angelo Sambunaris, M.D. · Atlanta Institute of Medicine and Research

• Bijan Bastani, M.D. · NorthCoast Clinical Trials

• Mary Stedman, M.D. · Stedman Clinical Trials

• Richard Weisler, M.D. · Richard H. Weisler, M.D. and Associates

• Mark Joyce, M.D. · Clinical Neuroscience Solutions, Inc.

• Fares Arguello, MD · Radiant Research

• Valerie Arnold, MD · Clinical Neurosciences Solutions, Inc.

• Arif Khan, MD · Northwest Clinical Research Center

• Irving Kolin, MD · Kolin Research Group

• Jelena Kunovac, MD · Excell Research

• Jerry Steiert, MD · Summit Research Network (Seattle) LLC

• Lorena Wallhauser, MD · Patient Priority Clinical Sites, LLC

• Mohammed Bari, MD · Synergy Clinical Research Center

• Prakash Bhatia, MD · Synergy Escondido

• Michael Downing, MD · FutureSearch Trials of Dallas

• David Brown, MD · Community Clinical Research, Inc.

• Rosario Hidalgo, MD · University of South Florida College of Medicine Psychiatry Center

• Alec Bodkin, MD · Mclean Hospital

• Russell Pet, MD · AccelRx Research

• Beal Essink, M.D. · Oregon Center for Clinical Investigations, Inc

• Scott Segal, M.D. · The Segal Institute of Clinical Research

• Jeffrey Simon, M.D. · Northbrooke Research Center

• Charmaine Semeniuk, M.D. · Pacific Clinical Research

• John Prater, M.D. · Gulfcoast Clinical Research Center

• Mark Woyshville, M.D. · North Star Medical Research LLC

• Nathan Shapira, MD, Ph.D · Carman Research

• Robert Molpus, MD · Clinical Neuroscience Solutions, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2012-05-31

Completion

2012-05-31

Countries

• United States

Study Locations