SOURCE: Neuropsychopharmacology. 46(2):462-469, 2021 01.
AUTHORS: Croarkin PE; Elmaadawi AZ; Aaronson ST; Schrodt GR Jr; Holbert RC; Verdoliva S; Heart KL; Demitrack MA; Strawn JR Institution Croarkin, Paul E. Division of Child and Adolescent Psychiatry and Psychology, Mayo Clinic Depression Center, Mayo Clinic, Rochester, Minnesota, USA. croarkin.paul@mayo.edu. Elmaadawi, Ahmed Z. Beacon Health System, South Bend, Indiana USA, Indiana University School of Medicine, South Bend, USA. Aaronson, Scott T. Sheppard Pratt Health System, Baltimore, Maryland, USA. Schrodt, G Randolph Jr. Integrative Psychiatry, Louisville, Kentucky, USA. Holbert, Richard C. Shands Psychiatric Hospital, Gainesville, Florida, USA. Verdoliva, Sarah. North American Science Associates, Inc. (NAMSA) Minneapolis, Minnesota, USA. Heart, Karen L. Neuronetics, Inc. Malvern, Pennsylvania, USA. Demitrack, Mark A. Trevena, Inc. Chesterbrook, Pennsylvania, USA. Strawn, Jeffrey R. Department of Psychiatry & Behavioral Neuroscience, University of Cincinnati, Cincinnati, Ohio, USA.
Abstract
Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], – 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.
