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

Phase 3 Completed 2409 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: 2010-06
Primary completion: 2012-01
Completion: 2012-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 0.5 mg BID TC-5214 vs Placebo; p = 1.000; LS mean -0.9 (95% CI -2.96 to 1.24); MMRM NCT01153347 ↗

paper No statistically significant improvements in MADRS total score or any secondary endpoints were seen with TC-5214 versus placebo in either study at treatment end. PMID 25602163 ↗

Publications

Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dexmecamylamine	Other / unclassified	0.5 mg	Oral
Subject	dexmecamylamine	Other / unclassified	2 mg	Oral
Subject	dexmecamylamine	Other / unclassified	4 mg	Oral