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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)

Morriss, Richard; Webster, Lucy; Abdelghani, Mohamed; Auer, Dorothee; 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

Authors

RICHARD MORRISS richard.morriss@nottingham.ac.uk
Professor of Psychiatry & Community Mental Health

Lucy Webster

Mohamed Abdelghani

Shaun Barber

Peter Bates

Andrew Blamire

Paul M. Briley

Cassandra Brookes

Sarina Iwabuchi

MARILYN JAMES MARILYN.JAMES@NOTTINGHAM.AC.UK
Professor of Health Economics

Catherine Kaylor-Hughes

Sudheer Lankappa

Hamish McAllister-Williams

Alex O’Neill-Kerr

Ana Suazo Di Paola

Yvette Walters



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 (a) cgiTBS or (b) 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 (MGH) 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 United Kingdom. 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 post randomisation. Cost effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.

Citation

Morriss, R., Webster, L., Abdelghani, M., Auer, D., Barber, S., Bates, P., …Walters, Y. (2020). 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). BMJ Open, 10(7), https://doi.org/10.1136/bmjopen-2020-038430

Journal Article Type Article
Acceptance Date May 20, 2020
Online Publication Date Jul 7, 2020
Publication Date Jul 7, 2020
Deposit Date Jun 8, 2020
Publicly Available Date Jul 7, 2020
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 10
Issue 7
Article Number e038430
DOI https://doi.org/10.1136/bmjopen-2020-038430
Keywords General Medicine
Public URL https://nottingham-repository.worktribe.com/output/4607324
Publisher URL https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342821/

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Publisher Licence URL
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