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Author Notes:

Address correspondence to: Maurizio Fava, M.D., Director, Division of Clinical Research of the MGH Research Institute, Executive Vice Chair, Department of Psychiatry Executive Director, Clinical Trials Network and Institute (CTNI), Massachusetts General Hospital (MGH), Associate Dean for Clinical and Translational Research, Slater Family Professor of Psychiatry, Harvard Medical School , Mailing Address: Massachusetts General Hospital, 55 Fruit Street, Bulfinch 351, Boston MA 02114 , Tel: 617-724-0838, Fax: 617-726-2688 , mfava@mgh.harvard.edu.

We would like to thank Drs. Mi Hillefors, Steven Zalcman, Adam Haim, and Galia Siegel, for their support, which was absolutely critical to both the planning and the implementation of the study.

Subjects:

Research Funding:

This project was funded by the National Institute of Mental Health under Contract Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID) Number: HHSN271201100006I, Task Order Number: HHSN27100002, to the Massachusetts General Hospital (Maurizio Fava, MD and George Papakostas, co-principal investigators).

The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

Tal Medical, Inc. provided the study treatment devices at no cost for this trial.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Clinical Neurology
  • Neurosciences
  • Neurosciences & Neurology
  • Low-field magnetic stimulation
  • Major depressive disorder
  • POOLED ANALYSIS
  • RATING-SCALE
  • PLACEBO
  • EFFICACY
  • DISORDER
  • SAFETY
  • QUESTIONNAIRE
  • RELIABILITY
  • COMBINATION
  • DEFINITION

Double-blind, proof-of-concept (POC) trial of Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy in treatment-resistant depression (TRD)

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Journal Title:

Brain Stimulation

Volume:

Volume 11, Number 1

Publisher:

, Pages 75-84

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background Low-Field Magnetic Stimulation (LFMS) is a novel, non-invasive, sub-threshold neuromodulation technique, shown in preliminary studies to have immediate mood elevating effects in both unipolar and bipolar depressed patients. Objective We aimed to assess the antidepressant augmentation effects at 48 h of LFMS administered on two consecutive days compared to sham treatment in treatment resistant depression (TRD) subjects, using the Sequential Parallel Comparison Design (SPCD). Methods Eighty-four eligible subjects with TRD were randomly assigned to double-blind treatment with LFMS 20 min/day for four days, sham treatment 20 min/day for four days, or sham treatment 20 min/day for 2 days followed by LFMS treatment 20 min/day for two days, using the pre-randomization version of the SPCD (randomization 1:1:1). The SPCD analyses used a repeated measures linear modeling approach with maximum likelihood estimation to use all available data, and using a 60–40 weighting of Stage 1 vs. 2 responses, with the primary outcome being measured after 2 and 4 days. Results Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients. LFMS treatment was relatively well tolerated. Conclusions We did not observe a significantly greater, rapid efficacy of LFMS compared to sham therapy. Future studies need to examine the possible therapeutic effects of more intensive forms of LFMS, as other forms of neurostimulation typically require longer duration of exposure.

Copyright information:

© 2017 Elsevier Inc.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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