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Trials. 2017 Sep 2;18(1):409. doi: 10.1186/s13063-017-2125-y.

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

Author information

1
Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, Perry Point, MD, USA.
2
Department of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
3
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
4
Department of Veterans Affairs, Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, NM, USA.
5
Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
6
Department of Veterans Affairs, VA Medical Center, Pittsburgh, PA, USA.
7
Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
8
Department of Veterans Affairs, VA Medical Center, Philadelphia, PA, USA.
9
Department of Veterans Affairs, Cooperative Studies Program Central Office, Washington DC, USA.
10
Department of Veterans Affairs, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
11
Brain Stimulation Laboratory (BSL), Psychiatry Department, Medical University of South Carolina (MUSC), Charleston, SC, USA.
12
Department of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA. yesavage@stanford.edu.
13
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA. yesavage@stanford.edu.
14
VISN21 MIRECC, Department of Veterans Affairs, Department of Psychiatry, Stanford University School of Medicine, 3801 Miranda Avenue, Palo Alto, CA, 94304, USA. yesavage@stanford.edu.

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.

KEYWORDS:

Hamilton Rating Scale for Depression (HRSD24); Repetitive transcranial magnetic stimulation (rTMS); Treatment-resistant major depression (TRMD)

PMID:
28865495
PMCID:
PMC5581925
DOI:
10.1186/s13063-017-2125-y
[Indexed for MEDLINE]
Free PMC Article

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