Neuromodulatory treatments for psychiatric disease: A comprehensive survey of the clinical trial landscape.

Autor: Elias GJB; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada., Boutet A; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada; Joint Department of Medical Imaging, University of Toronto, Toronto, Canada., Parmar R; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Wong EHY; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Germann J; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada., Loh A; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada., Paff M; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Pancholi A; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Gwun D; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Chow CT; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Gouveia FV; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre & University of Toronto, Toronto, Canada., Harmsen IE; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada., Beyn ME; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada., Santarnecchi E; Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, United States., Fasano A; Krembil Research Institute, University of Toronto, Toronto, Canada; Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, University Health Network, Toronto, Canada; Center for Advancing Neurotechnological Innovation to Application, Toronto, Canada., Blumberger DM; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, University Health Network & University of Toronto, Toronto, Canada., Kennedy SH; Krembil Research Institute, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network & University of Toronto, Toronto, Canada; Centre for Depression & Suicide Studies, St. Michael's Hospital & University of Toronto, Toronto, Canada., Lozano AM; Division of Neurosurgery, Department of Surgery, University Health Network & University of Toronto, Toronto, Canada; Krembil Research Institute, University of Toronto, Toronto, Canada., Bhat V; Krembil Research Institute, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network & University of Toronto, Toronto, Canada; Centre for Depression & Suicide Studies, St. Michael's Hospital & University of Toronto, Toronto, Canada. Electronic address: venkat.bhat@utoronto.ca.
Jazyk: angličtina
Zdroj: Brain stimulation [Brain Stimul] 2021 Sep-Oct; Vol. 14 (5), pp. 1393-1403. Date of Electronic Publication: 2021 Aug 27.
DOI: 10.1016/j.brs.2021.08.021
Abstrakt: Background: Numerous neuromodulatory therapies are currently under investigation or in clinical use for the treatment of psychiatric conditions.
Objective/hypothesis: We sought to catalogue past and present human research studies on psychiatric neuromodulation and identify relevant trends in this field.
Methods: ClinicalTrials.gov (https://www.clinicaltrials.gov/) and the International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/) were queried in March 2020 for trials assessing the outcome of neuromodulation for psychiatric disorders. Relevant trials were categorized by variables such as neuromodulation modality, country, brain target, publication status, design, and funding source.
Results: From 72,086 initial search results, 1252 unique trials were identified. The number of trials registered annually has consistently increased. Half of all trials were active and a quarter have translated to publications. The largest proportion of trials involved depression (45%), schizophrenia (18%), and substance use disorders (14%). Trials spanned 37 countries; China, the second largest contributor (13%) after the United States (28%), has increased its output substantially in recent years. Over 75% of trials involved non-convulsive non-invasive modalities (e.g., transcranial magnetic stimulation), while convulsive (e.g., electroconvulsive therapy) and invasive modalities (e.g., deep brain stimulation) were less represented. 72% of trials featured approved or cleared interventions. Characteristic inter-modality differences were observed with respect to enrollment size, trial design/phase, and funding. Dorsolateral prefrontal cortex accounted for over half of focal neuromodulation trial targets. The proportion of trials examining biological correlates of neuromodulation has increased.
Conclusion(s): These results provide a comprehensive overview of the state of psychiatric neuromodulation research, revealing the growing scope and internationalism of this field.
Competing Interests: Declaration of competing interest This study was financially supported by the Canadian Institutes of Health Research (CIHR reference #164235: GJBE), the RR Tasker Chair in Functional Neurosurgery at University Health Network (AML), and an Academic Scholar Award from the University of Toronto Department of Psychiatry (VB). ES is supported by the Beth Israel Deaconess Medical Center (BIDMC), the Defense Advanced Research Projects Agency (DARPA), the National Institute of Health (NIH), the Alzheimer's Drug Discovery Foundation (ADDF), and the Association for Frontotemporal Dementia (AFTD). AML is the co-founder of Functional Neuromodulation, is a consultant for Boston Scientific, Medtronic, and Abbott, and holds intellectual property in the field of DBS. AF is a consultant for Medtronic, Boston Scientific, and Abbott. DMB has received research support from CIHR, NIH, Brain Canada, and the Temerty Family through the CAMH Foundation and the Campbell Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. and is the principal site investigator for three sponsor-initiated studies for Brainsway Ltd. DMB also received in-kind equipment support from Magventure for investigator-initiated research and received medication supplies for an investigator-initiated trial from Indivior. SHK has received honoraria or research funds from Abbott, Alkermes, Allergan, Boehringer Ingelheim, Brain Canada, CIHR, Janssen, Lundbeck, Lundbeck Institute, Ontario Brain Institute, Ontario Research Fund, Otsuka, Pfizer, Servier, Sunovion, and Sun Pharmaceuticals. He also holds stock in Field Trip Health. VB has received research support from the University of Toronto, CIHR, Brain & Behavior Foundation, MOH Innovation Funds, RCPSC, and DND Canada. He receives support for an investigator-initiated trial from Roche Canada. The other authors report no conflicts of interest.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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