At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 295 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 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
In Brief
A Phase 3 clinical trial evaluating TC-5214 and Placebo for Major Depressive Disorder and Depression. Completed, enrolled 295 participants across 66 sites in 10 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Depression
CountriesCzechia, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Poland, Sweden
CollaboratorsTargacept Inc.
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionSep 2011
TodayJul 2026
First PostedAug 12, 2010
Enrollment StartSep 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.9 years ago
Interventions
TC-5214drug
Tablet, oral, twice daily for 8 weeks
Placebodrug
Tablet, oral, twice daily for 8 weeks