rTMS combined with CBT as a next step in antidepressant non-responders: a study protocol for a randomized comparison with current antidepressant treatment approaches

BMC Psychiatry

Filip Smit¹  Hans van Mierlo²  Dieuwertje de Waardt³  Eric van Exel⁴  Philip van Eijndhoven⁵  Iris Dalhuisen⁵  Indira Tendolkar⁵  Jan Spijker⁶  Iris van Oostrom⁷  Martijn Arns⁸ 

[1] Department of Clinical Psychology and Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands;Department of Mental Health and Prevention, Trimbos Institute - Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands;Department of Psychiatry & Psychology, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands;Department of Psychiatry, ETZ Hospital (Elisabeth-TweeSteden Ziekenhuis), Tilburg, The Netherlands;Department of Psychiatry, GGZ inGeest Specialized Mental Health Care, Amsterdam, Netherlands;Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands;Donders Institute for Brain Cognition and Behavior, Centre for Medical Neuroscience, Nijmegen, The Netherlands;Depression Expertise Centre, Pro Persona Mental Health Care, Nijmegen, The Netherlands;Behavioral Science Institute, Radboud University, Nijmegen, The Netherlands;Neurocare, Nijmegen, The Netherlands;Research Institute Brainclinics, Nijmegen, The Netherlands;Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands;

关键词: rTMS;    Depression;    RCT;    (cost)-effectiveness;   

DOI  :  10.1186/s12888-022-03732-6

来源: Springer

【 摘 要 】

BackgroundMajor depressive disorder (MDD) is one of the most common psychiatric disorders, however, current treatment options are insufficiently effective for about 35% of patients, resulting in treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that is effective in treating TRD. Not much is known about the comparative efficacy of rTMS and other treatments and their timing within the treatment algorithm, making it difficult for the treating physician to establish when rTMS is best offered as a treatment option. This study aims to investigate the (cost-)effectiveness of rTMS (in combination with cognitive behavioral therapy (CBT) and continued antidepressant medication), compared to the next step in the treatment algorithm. This will be done in a sample of patients with treatment resistant non-psychotic unipolar depression.MethodsIn this pragmatic multicenter randomized controlled trial 132 patients with MDD are randomized to either rTMS or the next pharmacological step within the current treatment protocol (a switch to a tricyclic antidepressant or augmentation with lithium or a second-generation antipsychotic). Both groups also receive CBT. The trial consists of 8 weeks of unblinded treatment followed by follow-up of the cohort at four and 6 months. A subgroup of patients (n = 92) will have an extended follow-up at nine and 12 months to assess effect decay or retention. We expect that rTMS is more (cost-)effective than medication in reducing depressive symptoms in patients with TRD. We will also explore the effects of both treatments on symptoms associated with depression, e.g. anhedonia and rumination, as well as the effect of expectations regarding the treatments on its effectiveness.DiscussionThe present trial aims to inform clinical decision making about whether rTMS should be considered as a treatment option in patients with TRD. The results may improve treatment outcomes in patients with TRD and may facilitate adoption of rTMS in the treatment algorithm for depression and its implementation in clinical practice.Trial registrationThis trial is registered within the Netherlands Trial Register (code: NL7628, date: March 29th 2019).

【 授权许可】

CC BY