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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Authors: Zhibao Mi, Kousick Biswas, J. Kaci Fairchild, Anne Davis-Karim, Ciaran S. Phibbs, Steven D. Forman, Michael Thase, Gerald Georgette, Tamara Beale, David Pittman, Margaret Windy McNerney, Allyson Rosen, Grant D. Huang, Mark George, Art Noda, Jerome A. Yesavage

Published in: Trials | Issue 1/2017

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Abstract

Background

Evaluation of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) in Veterans offers unique clinical trial challenges. Here we describe a randomized, double-blinded, intent-to-treat, two-arm, superiority parallel design, a multicenter study funded by the Cooperative Studies Program (CSP No. 556) of the US Department of Veterans Affairs.

Methods

We recruited medical providers with clinical expertise in treating TRMD at nine Veterans Affairs (VA) medical centers as the trial local investigators. We plan to enroll 360 Veterans diagnosed with TRMD at the nine VA medical centers over a 3-year period. We will randomize participants into a double-blinded clinical trial to left prefrontal rTMS treatment or to sham (control) rTMS treatment (180 participants each group) for up to 30 treatment sessions. All participants will meet Diagnostic and statistical manual of mental disorders, 4 th edition (DSM-IV) criteria for major depression and will have failed at least two prior pharmacological interventions. In contrast with other rTMS clinical trials, we will not exclude Veterans with posttraumatic stress disorder (PTSD) or history of substance abuse and we will obtain detailed history regarding these disorders. Furthermore, we will maintain participants on stable anti-depressant medication throughout the trial. We will evaluate all participants on a wide variety of potential predictors of treatment response including cognitive, psychological and functional parameters.

Discussion

The primary dependent measure will be remission rate (Hamilton Rating Scale for Depression (HRSD24) ≤ 10), and secondary analyses will be conducted on other indices. Comparisons between the rTMS and the sham groups will be made at the end of the acute treatment phase to test the primary hypothesis. The unique challenges to performing such a large technically challenging clinical trial with Veterans and potential avenues for improvement of the design in future trials will be described.

Trial registration

ClinicalTrials.gov, NCT01191333. Registered on 26 August 2010. This report is based on the protocol version 4.6 amended in February 2016. All items from the World Health Organization Trial Registration Data Set are listed in Appendix A.
Appendix
Available only for authorised users
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Metadata
Title
Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial
Authors
Zhibao Mi
Kousick Biswas
J. Kaci Fairchild
Anne Davis-Karim
Ciaran S. Phibbs
Steven D. Forman
Michael Thase
Gerald Georgette
Tamara Beale
David Pittman
Margaret Windy McNerney
Allyson Rosen
Grant D. Huang
Mark George
Art Noda
Jerome A. Yesavage
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2125-y

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