Status:
COMPLETED
A Study to Assess the Long- Term 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
MDD
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 for 52 weeks wit...
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.
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT01152554
Start Date
June 1 2010
End Date
February 1 2012
Last Update
April 11 2014
Active Locations (94)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Tuscaloosa, Alabama, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
Little Rock, Arkansas, United States