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

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.

Timeline

Start

2010-09

Primary completion

2012-01

Completion

2012-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 0.1 mg BID TC-5214 vs Placebo; p = 1.000; LS mean 1.1 (95% CI -0.53 to 2.79); MMRM; NCT01197508 ↗

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

Indications