At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 696 enrolled
Drug / intervention
TC-5214 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating TC-5214 and Placebo for Major Depressive Disorder. Completed, enrolled 696 participants across 87 sites in 17 countries.
Detailed 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 another antidepressant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesArgentina, Brazil, Bulgaria, Chile, Colombia, Croatia, France, Germany, Hungary, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine
CollaboratorsTargacept Inc.
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedSep 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.8 years ago
Interventions
TC-5214drug
Twice daily for 8 weeks.
Placebodrug
Twice daily for 8 weeks.