Home-based transcranial direct current stimulation for major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-centre, pragmatic randomized controlled trial comparing 10 weeks of active home-based transcranial direct current stimulation (tDCS) plus treatment as usual (TAU) versus TAU alone. About 438 adults with DSM-5 major depressive disorder and at least moderate symptoms will be randomized and followed for six months from treatment start. The primary outcome is clinician-rated depressive symptoms (MADRS); secondary outcomes include self-report mood, anxiety, remission rates, acceptability, quality of life, and health economic measures. The trial includes process and implementation work to examine feasibility and pathways for integrating home tDCS into NHS care.

Why it matters

Who can join: the full rules

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

Where it's running

• South London and Maudsley NHS Foundation Trust
  London, United Kingdom Recruiting
• Cardiff and Vale Health Board
  Cardiff, United Kingdom Not yet recruiting
• Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  Newcastle, United Kingdom Not yet recruiting
• Northamptonshire Healthcare NHS Foundation Trust
  Northampton, United Kingdom Not yet recruiting
• Nottinghamshire Healthcare NHS Foundation Trust
  Nottingham, United Kingdom Not yet recruiting
• Hampshire and Isle of Wight Healthcare NHS Foundation Trust
  Southampton, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Cynthia Fu, MD, PhD — King's College London
• Study coordinator: Cynthia Fu
• Email: cynthia.fu@kcl.ac.uk
• Phone: 020 7848 0002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.