A study to assess the efficacy and safety of TC-5214 as an adjunct therapy in patients with major depressive disorder (MDD)

Study identifier:D4130C00002

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 Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder with 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

319

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011

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

Sponsors

AstraZeneca

Collaborators

Targacept Inc.

Inclusion and exclusion criteria