A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

Phase 3 Completed 295 enrolled AstraZeneca Targacept Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-09
Primary completion: 2011-09
Completion: 2011-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); TC-5214 vs Placebo; p = 0.944; LS mean -0.1 (95% CI -1.86 to 1.73); MMRM; NCT01180400 ↗

paper At treatment end, no significant differences were seen for change in MADRS total score with TC-5214 versus placebo. PMID 24507016 ↗

Publications

Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dexmecamylamine	Other / unclassified	1 mg	Oral
Subject	dexmecamylamine	Other / unclassified	4 mg	Oral