Status:
COMPLETED
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Targacept Inc.
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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 investigational product.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
2409 Patients enrolled
Trial Details
Trial ID
NCT01153347
Start Date
June 1 2010
End Date
January 1 2012
Last Update
April 11 2014
Active Locations (99)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Tucson, Arizona, United States
3
Research Site
Conway, Arkansas, United States
4
Research Site
Little Rock, Arkansas, United States