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Article History

Received: 10 March 2025

Accepted: 5 October 2025

First Online: 4 December 2025

Declarations

:

: This study was carried out in accordance with the Declaration of Helsinki. Ethics approval for the clinical trial was provided by South Central-Hampshire B Research Ethics Committee, UK, and WIRB-Copernicus Group International Review Board, USA. Multisite, double-blind, placebo-controlled, randomized, superiority trial of home-based tDCS in MDD (ClinicalTrials.gov NCT05202119). The privacy and rights of human subjects was observed at all times.

: All participants provided written informed consent for their participation.

: ‘ Not Applicable’ in this section.

: CF acknowledges grant funding from National Institute of Mental Health (R01MH134236), Milken Institute Baszucki Brain Research (BD00029), Rosetrees Trust (CF20212104), International Psychoanalytical Association (IPA158102845). SS reports the following declaration of interests: Research grant funding on behalf of the University of Texas Health Science Center at Houston from Flow Neuroscience. SS is a fulltime employee of Intra-Cellular Therapies, Inc. He is also served as paid advisory boards for the following companies: Worldwide Clinical Trials and Inversago; Vicore pharma. He has received grants/research support from NIMH, United States (1R21MH119441-01A1), NIMH (1R21MH129888-01A1), NICHD 1R21HD106779-01A1, and SAMHSA (6H79FG000470-01M003). He has received research funding as a Principal investigator or study/sub-investigator from and/or participated as consultant/speaker for Flow Neuroscience, COMPASS Pathways, LivaNova, Janssen, Relmada, and Psychiatry education forum. Intra-Cellular Therapies (ITI) or NIH or SAMHSA or any other organizations had no role in the study’s design and conduct; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. This study’s content is solely the responsibility of the authors and does not necessarily represent the official views of the ITI or NI. Author AY reports the following declaration of interests: Paid lectures and advisory boards for the following companies with therapies used in affective and related disorders: Flow Neuroscience, Novartis, Roche, Janssen, Takeda, Noema pharma, Compass, Astrazenaca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, Sage, Novartis, Neurocentrx. Principal Investigator for the following studies: (1) the Restore-Life VNS registry study funded by LivaNova; (2) ESKETINTRD3004: “An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression”; (3) The Effects of Psilocybin on Cognitive Function in Healthy Participants; (4) The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD); (5) A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy. (Janssen); (6) An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants with Major Depressive Disorder (MDD). (Janssen); (7) A Randomized, Double-blind, Multicentre, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy; (8) A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients with Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNR. (Janssen). UK Chief Investigator for the following studies: (1) Novartis MDD study MIJ821A12201; (2) Compass; COMP006 & COMP007 studies. Grant funding (past and present): NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK). Janssen (UK) EU Horizon 2020. Editor of Journal of Psychopharmacology and Deputy Editor, BJPsych Open. No shareholdings in pharmaceutical companies. Author RM-V has received consulting fees from Eurofarma Pharmaceuticals, Abbott, and BioStrategies group; has research contracts with Boerhinger Ingelheim and Janssen Pharmaceuticals; has received speaker fees from Otsuka, EMS, and Cristalia, member of the scientific boards of Symbinas Pharmaceuticals and Allergan. Author R.M-V is also the PI for the following grants: NIH (R21HD106779 and R21MH129888), Milken Institute (BD-0000000081).HR acknowledges funding from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) grant number GRK2773/1-454245598. Authors AG, GS, HH, JS, NL, PL, MR, PO, SK, and RW declare no competing interests.