A study to assess the long- term safety of TC-5214 as an adjunct therapy in patients with major depressive disorder

Study identifier:D4130C00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate response to Antidepressant Therapy

Medical condition

Major depressive disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

TC-5214, Placebo

Sex

All

Actual Enrollment

813

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Feb 2012
Study Completion Date: 01 Feb 2012

Study design

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

Verification:

Verified 01 Mar 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Targacept

Inclusion and exclusion criteria