H B Solvason1, M Husain2, P B Fitzgerald3, P Rosenquist4, W V McCall4, J Kimball5, W Gilmer6, M A Demitrack7, S H Lisanby8. 1. Department of Psychiatry, Stanford University Medical Center, Stanford University, 401 Quarry Road, Palo Alto, CA 94305 USA. Electronic address: solvason@mac.com. 2. University of Texas Southwestern Medical School, Dallas, TX, USA. 3. The Alfred Hospital, Melbourne, Australia. 4. Medical College of Georgia, Augusta, GA, USA. 5. Wake Forest University, Winston-Salem, NC, USA. 6. Northwestern University, Chicago, IL, USA. 7. Neuronetics, Inc., Malvern, PA, USA. 8. Duke University, Durham, NC, USA.
Abstract
BACKGROUND:Transcranial magnetic stimulation (TMS) is a safe and effective treatment for major depression. We describe quality of life (QOL) outcomes from acute treatment with TMS, and describe the durability of benefit across 24-weeks. METHODS:Three hundred and one medication-free patients with pharmacoresistant major depression were randomized to active or sham TMS in a 6-week controlled trial. Nonresponders to the 6-week blinded phase of the study were enrolled in a 6-week open-label study without unblinding the prior treatment assignment. Responders and partial responders to both the blinded (active or sham treatment) or open acute treatment phases were tapered off TMS over three weeks, while initiating maintenance antidepressant medication monotherapy. These subjects entered the 24-week study to examine the durability of response to TMS. The Medical Outcomes Study-36 Item Short Form (SF-36) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) were used to measure overall function and QOL. During the 24-week durability of effect study, QOL assessments were done at study entry and at the end of 24-weeks. RESULTS: Statistically significant improvement in both functional status and QOL outcomes was observed in patients treated with active TMS compared with sham TMS during the acute phase of the randomized, sham-controlled trial. Similar benefits were observed in patients who entered the open-label extension study. These improvements were sustained across the 24-week follow up study. CONCLUSIONS: Acute treatment with TMS improved functional status and QOL outcomes in patients with major depression. This clinical effect was durable in long-term follow up.
RCT Entities:
BACKGROUND: Transcranial magnetic stimulation (TMS) is a safe and effective treatment for major depression. We describe quality of life (QOL) outcomes from acute treatment with TMS, and describe the durability of benefit across 24-weeks. METHODS: Three hundred and one medication-free patients with pharmacoresistant major depression were randomized to active or sham TMS in a 6-week controlled trial. Nonresponders to the 6-week blinded phase of the study were enrolled in a 6-week open-label study without unblinding the prior treatment assignment. Responders and partial responders to both the blinded (active or sham treatment) or open acute treatment phases were tapered off TMS over three weeks, while initiating maintenance antidepressant medication monotherapy. These subjects entered the 24-week study to examine the durability of response to TMS. The Medical Outcomes Study-36 Item Short Form (SF-36) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) were used to measure overall function and QOL. During the 24-week durability of effect study, QOL assessments were done at study entry and at the end of 24-weeks. RESULTS: Statistically significant improvement in both functional status and QOL outcomes was observed in patients treated with active TMS compared with sham TMS during the acute phase of the randomized, sham-controlled trial. Similar benefits were observed in patients who entered the open-label extension study. These improvements were sustained across the 24-week follow up study. CONCLUSIONS: Acute treatment with TMS improved functional status and QOL outcomes in patients with major depression. This clinical effect was durable in long-term follow up.
Authors: Heidemarie Lex; Yarden Ginsburg; Adam F Sitzmann; Clara Grayhack; Daniel F Maixner; Brian J Mickey Journal: J Affect Disord Date: 2018-09-19 Impact factor: 4.839
Authors: Tarique Perera; Mark S George; Geoffrey Grammer; Philip G Janicak; Alvaro Pascual-Leone; Theodore S Wirecki Journal: Brain Stimul Date: 2016-03-16 Impact factor: 8.955