A study to assess the safety and effect of TC-5214 in patients with major depressive disorder.
Study identifier:D4131C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Major depressive disorder
Phase
Phase 2
Healthy volunteers
No
Study drug
TC-5214, Duloxetine, Placebo
Sex
All
Actual Enrollment
145
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Aug 2012
Study Completion Date: 01 Aug 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Hans A Eriksson
AstraZeneca R&D Södertälje
