Safety and efficacy of Deep TMS for adolescent depression based on large real-world data analysis

Abstract

Adolescent major depressive disorder (MDD) is a prevalent and serious mental health condition. Pharmacological treatments are commonly used but often have poor tolerability and severe side effects, such as suicidal ideation. Deep transcranial magnetic stimulation (TMS) is currently cleared treating MDD in individuals 22-86 years old. This post-marketing surveillance study was designed to evaluate the safety and efficacy of using this tool as a treatment for MDD in younger patients. Data were collected from 56 sites, resulting in 1257 patients that met inclusion criteria (e.g. 11-21 years old, H1 coil, 18 Hz or iTBS, treatment-resistant MDD). Treatment was well tolerated in these younger patients, with an adverse event rate comparable to adults. After 30 sessions the response/remission rates were HDRS: 58.3 %/ 48.6 %, PHQ9:64.4 %, 25.5 %. After 36 sessions the response/remission rates were HDRS: 75.0 %/58.3 %, PHQ9:74.6 %/34.6 %. Median onset of response & remission was after 13 & 20 sessions respectively. Kaplan-Meier analysis showed 80 % of patients responded by 20 sessions and 90 % by 36 sessions. The outcomes from iTBS (1800 pulses) and 18 Hz were not significantly different (Fisher's exact test, p>0.05). There was a significant decrease in depression severity after treatment (p<0.0001, Chi-square test; PHQ-9 categorical distribution). Anxiety symptoms also improved in the majority of patients, with a response/remission rate of 66 %/40.2 % after 36 sessions (GAD-7). As the largest naturalistic study to date, these data demonstrate Deep TMS is a safe and effective therapeutic option for adolescents and young adults suffering from MDD when delivered under routine outpatient treatment conditions.

Keywords: Adolescents; Deep TMS; Depression; Real world evidence; rTMS.