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).

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.

Impact of repetitive transcranial magnetic stimulation on generalized anxiety disorder in treatment-resistant depression.

BACKGROUND: Published evidence indicates the value of repetitive transcranial magnetic stimulation (rTMS) for generalized anxiety disorder in patients with treatment-resistant depression (TRD). As a part of routine clinical service, patients with TRD received right dorsolateral prefrontal cortex (DLPFC) inhibitory rTMS immediately prior to left DLPFC depression treatment delivered according to a US Food and Drug Administration protocol. METHODS: A retrospective investigation of routinely collected data between 2016 and 2018 was undertaken. Measures used were the clinicianrated Clinical Global Impressions-Severity (CGI-S) scale and Hamilton Depression Rating scale (HAM-D), and the patient-rated Generalized Anxiety Disorder scale-7 (GAD-7) and Patient Health Questionnaire (PHQ-9). The outcome data of 61 patients with TRD were analyzed. The sample included patients with comorbid psychiatric diagnoses. RESULTS: Response and remission rates, respectively, were 17.1% and 27.3% on the GAD-7; 20.7% and 12.5% on the HAM-D; 19% and 24% on the PHQ-9; and 20% and 23.5% on the CGI-S. Post-treatment scores significantly improved on the GAD-7, HAM-D, and CGI-S scales, with medium to large effect sizes (.61, .62, and .86 respectively). CONCLUSIONS: Results indicate the potential value of rTMS in treating anxiety in patients who are referred for rTMS for TRD. Well-designed and adequately powered randomized controlled trials are required to determine clinical recommendations.

Patients', Carers', and the Public's Perspectives on Electroconvulsive Therapy.

Aims and Method: The aim of this study was to present patients', carers', and the public's perspectives on electroconvulsive therapy (ECT) through a narrative review of the literature. Results: People's perspectives on ECT are often negative due to media and Internet portrayal. Perspectives are influenced by risks, short-term side effects, and the most commonly reported longer-term side effect: memory loss. However, many patients do not report memory loss. Most people who experience ECT and their carers report a positive perspective. In the future, people's perspectives may become more positive with higher service delivery standards and a more balanced, well-informed view of modern ECT presented by the media. However, ECT has risks and side effects, and negative and critical perspectives on the use and effects of ECT will persist. Clinical Implications: Perspectives on ECT are important because of the impact on stigma, patient treatment choice, patient consent, and provision of and referral for ECT.

Repetitive transcranial magnetic stimulation (rTMS) for depression: outcomes in a United Kingdom (UK) clinical practice.

Objective: The aim of this paper is to present the outcomes data from the largest United Kingdom's (UK) National Health Service (NHS) clinical rTMS service treating treatment resistant depression (TRD). Methods: The study was a retrospective investigation of routinely collected data on patients receiving rTMS between 2015 and 2017. Measures used were the clinician-rated Clinical Global Impression (CGI) and Hamilton Depression Rating Scale (HAM-D), and patient rated Beck Depression Inventory (BDI). The outcome data of 73 patients with TRD were analysed. The sample included patients with co-morbid psychiatric diagnosis. Results: Response and remission rates, respectively, were 40.4% and 25.5% for the HAM-D; 35.6% and 20.8% for the BDI; and 51.1% and 52.1% for the CGI. Effect sizes were medium (0.54, 0.52 and 0.56, respectively). Conclusions: The results show that a UK-based clinical service achieves similar results to those published internationally and that clinical rTMS can have significant impact on symptoms of depression in many patients with TRD. Health services are under pressure to make financial savings, investment in rTMS could reduce the long-term treatment costs associated with TRD.

Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

OBJECTIVE: The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. METHODS: This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. RESULTS: We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. CONCLUSIONS: Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

Should Nurses Administer Electroconvulsive Therapy?

In England, electroconvulsive therapy (ECT) has been traditionally administered by trainee or consultant psychiatrists with support from nurses. We believe that providing senior nurses, who specialize in ECT, with the appropriate training support to administer ECT will increase the capacity and capability of the team and improve the service for patients.

The Development and Use of a Modified WHO Checklist for Use in Electroconvulsive Therapy.

The World Health Organization checklist is proven to reduce morbidity and mortality and is mandatory in operating theater settings, but not for electroconvulsive therapy (ECT) in the UK. We believe that such a checklist is especially relevant in an ECT setting because of the high turnover of short cases and for specific checks particularly pertinent to ECT patients. Our ECT team has developed a checklist with the headings Sign In, Psychiatric Concerns, Anesthetic Concerns, and Recovery, which we have found efficacious. We recommend that all centers offering ECT develop their own World Health Organization checklist to improve patient safety.