Study identifier:D4131C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Major depressive disorder
Phase 2
No
TC-5214, Duloxetine, Placebo
All
145
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.
Location
Location
Beverly Hills, CA, United States
Location
Chino, CA, United States
Location
Garden Grove, CA, United States
Location
San Diego, CA, United States
Location
Torrance, CA, United States
Location
Bradenton, FL, United States
Location
Coral Springs, FL, United States
Location
Jacksonville, FL, United States
Arms | Assigned Interventions |
---|---|
Experimental: 1 TC-5214, 1 mg BID | Drug: TC-5214 Tablet, oral, twice daily for 8 weeks |
Experimental: 2 TC-5214, 4 mg BID | Drug: TC-5214 Tablet, oral, twice daily for 8 weeks |
Active Comparator: 3 Duloxetine 60 mg Q Day | Drug: Duloxetine Capsule, oral, once daily |
Placebo Comparator: 4 Placebo | Drug: Placebo Tablet, oral, twice daily for 8 weeks |
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