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). Issue 7 (7th July 2020)

• Record Type: Journal Article
• 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
• Other Names: author non-byline.; Bastick Lorraine author non-byline.; Carr Rosie author non-byline.; Cartlidge Alison author non-byline.; Clark Harry author non-byline.; Cottam William author non-byline.; Vai Robert De author non-byline.; Davison Linda author non-byline.; Gledhill John author non-byline.; Gregory Adele author non-byline.; Griffiths Christopher author non-byline.; Hamilton Andrew author non-byline.; Harding Delilah author non-byline.; Heath Kelly author non-byline.; Hobson Rachel author non-byline.; Ireoluwa Gbeminiyi author non-byline.; Khalifa Najat author non-byline.; Johnstone Kate author non-byline.; Kirkland Charlotte author non-byline.; Liddle Mark author non-byline.; Lynch Jessica author non-byline.; Nixon Neil author non-byline.; Parikh Jehill author non-byline.; Reid Isabel author non-byline.; Reiner Noemi author non-byline.; Simpson Sandra author non-byline.; Smith Beverley author non-byline.; Sore Tina author non-byline.; Stone Joseph author non-byline.; Taylorson Carly author non-byline.; Toney Rebecca author non-byline.; Turner Claire author non-byline.; Wilkinson Sarah author non-byline.; Willis Andy author non-byline.; Willis Tom author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 7(2020)
• Publication Date: 2020-07-07
• Subjects: depression & mood disorders -- magnetic resonance imaging -- health economics -- adult psychiatry -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-038430
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: The 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 analysis: The 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 dissemination: Ethical 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 number: ISRCTN19674644