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
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 a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with ...
Detailed Description
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in...
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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT01197508
Start Date
September 1 2010
End Date
January 1 2012
Last Update
April 11 2014
Active Locations (87)
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1
Research Site
Buenos Aires, Buenos Aires F.D., Argentina
2
Research Site
Mendoza, Mendoza Province, Argentina
3
Research Site
Ciudad Autonoma Bs As, Cba, Argentina
4
Research Site
Dublin, Argentina