A study to assess the safety and effect of TC-5214 in patients with major depressive disorder.

Study identifier:D4131C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Medical condition

Major depressive disorder

Phase

Phase 2

Healthy volunteers

No

Study drug

TC-5214, Duloxetine, Placebo

Sex

All

Actual Enrollment

145

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Aug 2012
Study Completion Date: 01 Aug 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria