FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Transcranial direct-current stimulation did not show noninferiority to escitalopram for major depressive disorder in a single-center trial. The results were published online June 29.
The randomized double-blind placebo-controlled noninferiority study involved 245 adults with moderate to severe depression, many of whom had coexisting anxiety disorder. This “reflects a typical clinical population in which treatment for depression is indicated,” said André R. Brunoni, MD, PhD, of the Service of Interdisciplinary Neuromodulation, Institute of Psychiatry and Laboratory of Neurosciences, University of São Paulo, Brazil, and his associates.
A total of 94 patients were assigned to receive active tDCS plus oral placebo (tDCS group), 91 to receive sham tDCS plus escitalopram (escitalopram group), and 60 to receive sham tDCS plus oral placebo (placebo group) for 10 weeks. The primary outcome – decrease in mean depression score on the 17-item Hamilton Depression Rating Scale – was 9.0 points with tDCS, 11.3 points with escitalopram, and 5.8 points with placebo. Thus, tDCS did not achieve noninferiority to escitalopram, the investigators said (N Engl J Med. 2017 June 29. doi: 10.1056/NEJMoa1612999 ).
Although tDCS was superior to placebo in some secondary outcomes, including rate of clinical response (defined as a reduction of 50% or more in the Hamilton or the Montgomery-Åsberg Depression Rating Scale), it was associated with significantly more adverse events. The tDCS group reported more tinnitus, more nervousness, and more itching, tingling, burning, and skin redness at the electrode sites than did the other study groups. The escitalopram group reported higher rates of sleepiness and obstipation than did the other study groups.
One concerning finding was that two patients in the tDCS group developed new-onset mania during treatment, Dr. Brunoni and his associates noted.
“Future studies of tDCS could investigate different total doses of electrical stimulation in patients with major depressive disorder,” they wrote.
This trial was supported by the Fundacão de Amparo à Pesquisa do Estado de São Paulo, the Brain and Behavior Research Foundation, the Sao Paulo State Foundation, the National Council for Scientific and Technological Development, the Associacao Beneficente Alzira Denise Hertzog de Silva, and the Brazilian Coordination for the Improvement of Higher Education Personnel. Soterix Medical supplied the tDCS devices, and Libbs Laboratory supplied the escitalopram used in this study free of charge. Dr. Brunoni reported ties to Soterix Medical, Libbs Laboratory, and Delta Medical. His associates reported ties to numerous industry sources.