Abstract
Major Depressive Disorder (MDD) is a condition with high prevalence and morbidity worldwide. Treatments have limited efficacy and are curbed by adverse effects (Pharmacotherapy) or availability and costs (psychotherapy). Thus, developing novel interventions is tremendously relevant and can bring major gains in psychiatric care. Non-Implantable Neuromodulatory (NIN) approaches such as transcranial Direct Current Stimulation (tDCS) and Magnetic Seizure Therapy (MST) represent a third therapeutic principle, i.e. neuronal network modulation, which can benefit from making full use of the large body of data in MDD derived from neuroimaging and neurophysiology research. Moreover, the development of NIN addresses the need for innovative interventions in MDD. This project focuses on MDD at different stages of therapy-resistance and investigates tDCS and MST for gaining a deeper understanding of their mechanisms of action and developing both interventions towards a wider clinical application. Two Randomized Clinical Trials (RCTs) were designed to investigate the efficacy of state-of-the-art NIN techniques, which represent novel developments from previous NIN approaches that are only moderately effective or associated with cognitive side effects. RCT1 uses a 3-arm, double-blind design to compare the efficacy of 24 sessions (6 times per week in 3 weeks, then twice a week until week 6) home-use tDCS combined with internet-Based behavioral Therapy (iBT) modules versus tDCS-only and versus sham in 210 adult patients with unipolar depression. RCT2 uses a non-inferiority design to compare 8-16 sessions over 6 weeks of Magnetic Seizure Therapy (MST) versus ECT in treatment-resistant depressed, adult patients, considering both clinical efficacy and cognitive changes as co-primary outcomes. In addition, we will investigate cognition (module 1) and neuroimaging (module 2, only for RCT2) as putative clinical and biological endophenotypes that predict treatment response and change according to treatment. Predictors will be examined using statistical approaches and machine learning algorithms in the Prognostic Enhancement module (module 3). This thematic project will take place at two Institutions (University Hospital and Institute of Psychiatry at USP) with experience in trials using devices and includes an advisory board of international researchers from 12 universities in the US, Canada, UK, Australia, Germany, Switzerland, and Belgium that will leverage collaborations and dissemination of results. (AU)
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