Overview

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

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Targacept Inc.
Treatments:
Serotonin Uptake Inhibitors
Criteria
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