Study identifier:D4130C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Major depressive disorder
Phase 3
No
TC-5214, Placebo
All
295
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2014 by AstraZeneca
AstraZeneca
Targacept Inc.
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.
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Location
Location
Brno, Czech Republic
Location
Kutna Hora, Czech Republic
Location
Litomerice, Czech Republic
Location
Plzen, Czech Republic
Location
Praha 10, Czech Republic
Location
Praha 10 - Strasnice, Czech Republic
Location
Praha 2, Czech Republic
Location
Praha 5, Czech Republic
Arms | Assigned Interventions |
---|---|
Experimental: TC-5214 Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID | Drug: TC-5214 Tablet, oral, twice daily for 8 weeks |
Placebo Comparator: Placebo Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID | Drug: Placebo Tablet, oral, twice daily for 8 weeks |
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