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A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

NCT01288079 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2012-11-20

Study results available
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Summary

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Conditions

Interventions

DRUG

TC-5214

Tablet, oral, twice daily for 8 weeks

DRUG

Duloxetine

Capsule, oral, once daily

DRUG

Placebo

Tablet, oral, twice daily for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Hans A Eriksson, MD, PhD, MBA · AstraZeneca R&D Södertälje

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Estonia
  • Finland
  • India
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01288079 on ClinicalTrials.gov