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Recent findings from a randomized, sham-controlled trial suggest that noninvasive transcranial alternating current stimulation (tACS) could offer swift relief for individuals battling major depressive disorder (MDD). However, while the results are promising, experts caution that further investigation is necessary to fully validate its benefits.
The study, published online in the Journal of Clinical Psychiatry on April 22, revealed that both active and sham tACS groups experienced comparable improvements in self-reported depression severity. Nevertheless, post hoc analyses unveiled that active tACS outperformed the sham variant, particularly among women and those exhibiting high adherence to treatment.
Lead investigator Philip Gehrman, PhD, from the Department of Psychiatry at the University of Pennsylvania Perelman School of Medicine, expressed confidence in tACS as a viable treatment for MDD, especially for women, provided consistent usage. Co-investigator Kyle Lapidus, MD, PhD, of Affective Care in New York City, highlighted the rapid onset of benefits, observed as early as the first week of treatment and sustained throughout the study.
tACS delivers low-intensity, pulsed alternating current through scalp electrodes, with the study utilizing the OAK (version 2.0) tACS device from Fisher Wallace Laboratories. The trial involved 255 adults meeting MDD criteria, randomly assigned to receive at-home active or sham tACS sessions for four weeks.
Both groups exhibited significant improvements in depression scores at week 2, with no significant difference between them. However, a deeper analysis of participants with complete compliance during the initial 14 days showcased superior improvement in the active tACS group across multiple time points.
Notably, women showed the greatest response to active tACS compared to sham, exceeding established thresholds for clinical significance. The study noted minimal and mild side effects, underscoring the potential for rapid relief with limited adverse effects.
Despite these promising findings, limitations such as reliance on self-reported outcomes and the short treatment duration warrant cautious interpretation. Eric Bartky, MD, from Bartky HealthCare Center, LLC, stressed the need for longer studies to ascertain the durability of tACS efficacy in MDD.
In response to these calls for further investigation, Fisher Wallace Laboratories announced a new 12-week study, designed by Dr. Maurizio Fava of Massachusetts General Hospital, to evaluate treatment effectiveness and durability, with plans to seek FDA approval based on the results.
While the study’s findings offer hope for innovative depression treatments, experts urge a tempered approach. Roger McIntyre, MD, of the University of Toronto, emphasized the need for replication in larger studies before widespread adoption. Flavio Frohlich, PhD, from the University of North Carolina at Chapel Hill, echoed the sentiment, calling for caution in drawing definitive conclusions from the current findings.
The study was sponsored by Fisher Wallace Laboratories Inc., with several investigators disclosing financial ties to the company. Despite the promising nature of the results, the consensus remains that additional rigorous research is essential to fully understand tACS’ potential in addressing MDD.
