A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Depression

Treatments

Drug: Placebo

Drug: TC-5214

Study type

Interventional

Funder types

Industry

Identifiers

NCT01157078

D4130C00002

Details and patient eligibility

About

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Full description

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.

Enrollment

319 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of signed and dated informed consent before initiation of any study-related procedures.
The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
Out-patient status at enrollment and randomization.

Exclusion criteria

Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population