At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 813 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, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) 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 2 related conditions. Completed, enrolled 813 participants across 94 sites in 2 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 for 52 weeks with another antidepressant medicine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, MDD, Depression
CountriesPuerto Rico, United States
CollaboratorsTargacept Inc.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionFeb 2012
TodayJul 2026
First PostedJun 29, 2010
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.0 years ago
Interventions
TC-5214drug
Tablet, oral, twice daily for 52 weeks
Placebodrug
Tablet, oral, twice daily for 52 weeks