Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND)

• Published in: BMJ open Vol. 10; no. 7; p. e038430
• Main Authors: Morriss, Richard, Webster, Lucy, Abdelghani, Mohamed, Auer, Dorothee P, Barber, Shaun, Bates, Peter, Blamire, Andrew, Briley, Paul M, Brookes, Cassandra, Iwabuchi, Sarina, James, Marilyn, Kaylor-Hughes, Catherine, Lankappa, Sudheer, Liddle, Peter, McAllister-Williams, Hamish, O'Neill-Kerr, Alex, Pszczolkowski Parraguez, Stefan, Suazo Di Paola, Ana, Thomson, Louise, Walters, Yvette
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 07.07.2020; BMJ Publishing Group
• Series: Protocol
• Subjects: Adult; Antidepressants; Cost analysis; COVID-19; Depression; Depressive Disorder, Major - therapy; Depressive Disorder, Treatment-Resistant - therapy; Double-Blind Method; Double-blind studies; Electroconvulsive therapy; Humans; Massachusetts; Mental depression; Mental disorders; Mental Health; Pregnancy; Quality of Life; Randomized Controlled Trials as Topic; Spectrum analysis; Transcranial Magnetic Stimulation; Treatment Outcome; Massachusetts; United Kingdom > UK; adult psychiatry; magnetic resonance imaging; clinical trials; depression & mood disorders; health economics
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-038430

IntroductionThe BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.Methods and analysisThe study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.Ethics and disseminationEthical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.Trial registration numberISRCTN19674644