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

• Published in: Current controlled trials in cardiovascular medicine Vol. 18; no. 1; p. 409
• Main Authors: Mi, Zhibao, Biswas, Kousick, Fairchild, J Kaci, Davis-Karim, Anne, Phibbs, Ciaran S, Forman, Steven D, Thase, Michael, Georgette, Gerald, Beale, Tamara, Pittman, David, McNerney, Margaret Windy, Rosen, Allyson, Huang, Grant D, George, Mark, Noda, Art, Yesavage, Jerome A
• Format: Journal Article
• Language: English
• Published: England BioMed Central 02.09.2017; BMC
• Subjects: Affect; Antidepressants; Clinical Protocols; Clinical trials; Depressive Disorder, Major - diagnosis; Depressive Disorder, Major - physiopathology; Depressive Disorder, Major - psychology; Depressive Disorder, Major - therapy; Depressive Disorder, Treatment-Resistant - diagnosis; Depressive Disorder, Treatment-Resistant - physiopathology; Depressive Disorder, Treatment-Resistant - psychology; Depressive Disorder, Treatment-Resistant - therapy; Double-Blind Method; Drug use; Electroconvulsive therapy; Hamilton Rating Scale for Depression (HRSD24); Humans; Mental depression; Mental disorders; Mental health; Neuropsychological Tests; Post traumatic stress disorder; Prefrontal Cortex - physiopathology; Psychotherapy; Psychotropic drugs; Remission Induction; Repetitive transcranial magnetic stimulation (rTMS); Research Design; Study Protocol; Substance abuse treatment; Suicides & suicide attempts; Surveys and Questionnaires; Time Factors; Transcranial Direct Current Stimulation - adverse effects; Transcranial magnetic stimulation; Treatment Outcome; Treatment-resistant major depression (TRMD); United States; United States Department of Veterans Affairs; Veterans; Treatment-resistant major depression (TRMD); Repetitive transcranial magnetic stimulation (rTMS); Hamilton Rating Scale for Depression (HRSD24)
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-017-2125-y

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. 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 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. 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. 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.