A study to assess the efficacy and safety of TC-5214 as an adjunct therapy in patients with major depressive disorder.
Study identifier:D4130C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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 Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Medical condition
Major depressive disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
TC-5214, Placebo
Sex
All
Actual Enrollment
696
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Jan 2012
Study Completion Date: 01 Jan 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Targacept
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.1 mg BID TC-5214 Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID | Drug: TC-5214 Twice daily for 8 weeks. |
| Experimental: 1 mg BID TC-5214 Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID | Drug: TC-5214 Twice daily for 8 weeks. |
| Experimental: 4 mg BID TC-5214 Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID | Drug: TC-5214 Twice daily for 8 weeks. |
| Placebo Comparator: Placebo Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID | Drug: Placebo Twice daily for 8 weeks. |
Contacts
Investigators
Principal Investigator
Hans A Eriksson
AstraZeneca R&D
