A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Depression

MDD

Treatments

Drug: TC-5214

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152554

D4130C00007

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 for 52 weeks with another antidepressant medicine.

Enrollment

813 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.
Outpatient 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.
Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.