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A Study of CX157 (TriRima) for the Treatment of Depression

NCT00739908 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2012-06-27

Study results available
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Summary

The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.

Conditions

Interventions

DRUG

CX157 (TriRima)

Six capsules administered three times a day for six weeks.

DRUG

Placebo

Six capsules administered three times a day for six weeks.

Sponsors & Collaborators

  • CeNeRx BioPharma Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Burch, MD · CeNeRx BioPharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00739908 on ClinicalTrials.gov