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Randomized Controlled Trial
. 2025 Jun:186:23-32.
doi: 10.1016/j.jpsychires.2025.03.047. Epub 2025 Mar 26.

Home-based transcranial direct current stimulation for major depressive disorder: 6-month follow-up from randomised sham-controlled trial and open-label treatment phases

Rachel D Woodham  1 , Sudhakar Selvaraj  2 , Nahed Lajmi  3 , Harriet Hobday  3 , Gabrielle Sheehan  3 , Ali-Reza Ghazi-Noori  3 , Peter J Lagerberg  3 , Rodrigo Machado-Vieira  4 , Jair C Soares  4 , Allan H Young  5 , Cynthia H Y Fu  6
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Free article
Randomized Controlled Trial

Home-based transcranial direct current stimulation for major depressive disorder: 6-month follow-up from randomised sham-controlled trial and open-label treatment phases

Rachel D Woodham et al. J Psychiatr Res. 2025 Jun.
Free article

Abstract

Transcranial direct current stimulation (tDCS) is a potential home-based treatment for major depressive disorder (MDD). In our double-blind randomised controlled trial (RCT) (n = 174; UK and USA), a 10-week course of home-based tDCS demonstrated clinical efficacy (clinical response: 58.3 % active treatment arm and 37.8 % sham (p = 0.017). tDCS was delivered in a bifrontal montage, with anode over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC. Each session was 30 min, with active stimulation at 2 mA and sham at 0 mA, incorporating brief ramp-up and ramp-down phased. Following the 10-week RCT, all participants were offered active tDCS in a 10-week open-label treatment phase, with 111 participants completing this phase. UK cohort (n = 77 MDD) were invited for additional 3-month and 6-month follow-ups, extending the total study period to 11 months post-randomisation. Participants were able to continue using the tDCS device during follow-up. At least one follow-up visit was attended by 42 MDD participants (27 women). Device usage rates were 59 % at 3-month follow-up and 55 % at 6-month follow-up. Clinical response rate was 64 % at 3-month follow-up and 76 % at 6-month follow-up. Among participants who had shown a clinical response after the open-label phase, 90 % maintained their response at the 6-month follow-up. In summary, long-term follow-up showed high and sustained clinical response rates regardless of continued tDCS device use.

Keywords: Long term outcome; Major depression; Neuromodulation; Non-invasive; Transcranial direct current stimulation.

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Conflict of interest statement

Declaration of competing interest Author C.F. reports the following declaration of interests: Research grant funding on behalf of the University of East London from Flow Neuroscience (R102696); research grant funding: NIMH (R01MH134236), Baszucki Brain Research Fund Milken Institute (BD0000009), Rosetrees Trust (CF20212104), International Psychoanalytic Society (158102845), MRC (G0802594), NARSAD, Wellcome Trust. Associate Editor of Psychoradiology, Section Editor of Brain Research Bulletin. Author A.Y. 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 S.S. reports the following declaration of interests: S.S. is a fulltime employee of Intra-Cellular Therapies, Inc. Research grant funding on behalf of the University of Texas Health Science Center at Houston from Flow Neuroscience. 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, SAMHSA (6H79FG000470-01M003) and Fizer foundation. 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 NIH or SAMHSA. Author R.M-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). Authors A.G., G.S., H.H., J.S., N.L., P.L. and R.W. declare no competing interests.

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