Lamotrigine Augmentation in Resistant Depression

Summary

This study is intended to evaluate the efficacy and safety of lamotrigine as an antidepressant augmentation agent in a sample of individuals with major depression and a history of both prior non-response and prospective failure to respond to at least one adequate trial of an antidepressant (for a total of two failed trials).

Timeline

Start

2003-12

Primary completion

2006-07

Completion

2007-04

Outcome

Missed primary endpoint

paper Results of the primary efficacy analysis of the randomized patients using the MADRS, HDRS-17, CGI-S, and CGI-I did not demonstrate a statistically significant difference between lamotrigine and placebo groups PMID 21367355 ↗

Publications

• Results Barbee, J.G., Jamhour, N,J., Stewart, J.W., Shelton, R.C., Reimherr, F.W., Thompson, P.M., Conrad, E.J. &Thompson, T.R. (2007, May). Lamotrigine as an antidepressant augmentation in treatment refractory unipolar depression. Poster session presented at the annual meeting of the American Psychiatric Association, San Diego, CA.
• Results Barbee, J.G., Jamhour, N,J. & Conrad, E.J. (2007, June). Predictors of response to lamotrigine augmentation in treatment refractory unipolar depression. Poster session presented at the annual meeting of the New Clinical Drug Evaluation Unit, Boca Raton, FL.
• Barbee JG, Thompson TR, Jamhour NJ, Stewart JW, Conrad EJ, Reimherr FW, Thompson PM, Shelton RC. A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. J Clin Psychiatry. 2011 Oct;72(10):1405-12. doi: 10.4088/JCP.09m05355gre.

Drugs

Indications