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RECRUITING

NCT07228468

Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)

Sponsor: King's College London

View on ClinicalTrials.gov

Summary

Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether home-based tDCS is an effective treatment for major depression for adults with major depression. Participants will be randomised to receive either a 10-week course of active tDCS treatment in addition to their standard care (Treatment as Usual), or to only receive Treatment as Usual. Participants will be followed up for 6-months after the start of the treatment began. After the 6-month follow-up visit, all participants from both groups can choose to continue/start the tDCS treatment. There will be a final follow-up visit 3 months later (9 months from the original treatment start of the trial).

Official title: Home-Based Transcranial Direct Current Stimulation in Major Depressive Disorder: a Multi-Centre, Two-Parallel Group, Superiority Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

438

Start Date

2025-11-18

Completion Date

2027-12-31

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Major Depressive Disorder (MDD)

Interventions

DEVICE

transcranial direct current stimulation (tDCS)

Participants randomised to the tDCS treatment arm will use a tDCS device which is a headset with the anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4, respectively). Treatment protocol consists of 5 tDCS sessions per week for 3 weeks followed by 3 tDCS sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS stimulation is 2 mA for 30 minutes with gradual ramp up over 30 seconds at the start and end of each session.

Inclusion Criteria: 1. Adults aged 18 years or over 2. Current episode of depression based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (APA, 2013) for major depressive disorder (MDD) as assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998) 3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS 4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment. 5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment. 6. Being under the care of GP 7. Agreeable for GP to be regularly informed about study participation 8. Able to provide written, informed consent Exclusion Criteria: 1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011) 2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI 3. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines) 4. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of 8 or more in Alcohol use disorders identification test consumption (AUDIT C) (Khadjesari et al., 2017; NICE, 2023) 5. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation 6. History of esketamine / ketamine for treatment of depression 7. History of psychosurgery for depression 8. Having cognitive impairment (e.g. dementia) 9. Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease) 10. Have any implant in the brain or neurocranial defect 11. Have shrapnel or any ferromagnetic material in the head 12. Have any active implantable medical device (e.g. pacemaker) 13. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study 14. Concurrent enrolment in another interventional study

Locations (6)

Cardiff and Vale Health Board

Cardiff, United Kingdom

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle, United Kingdom

Northamptonshire Healthcare NHS Foundation Trust

Northampton, United Kingdom

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, United Kingdom

Hampshire and Isle of Wight Healthcare NHS Foundation Trust

Southampton, United Kingdom