RecruitingNot ApplicableNCT07228468

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

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

Sponsor

King's College London

Enrollment

438 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Adults aged 18 years or over
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)
Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS
Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.
Being under the care of GP
Agreeable for GP to be regularly informed about study participation
Able to provide written, informed consent

Exclusion Criteria14

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)
Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI
Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
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)
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
History of esketamine / ketamine for treatment of depression
History of psychosurgery for depression
Having cognitive impairment (e.g. dementia)
Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease)
Have any implant in the brain or neurocranial defect
Have shrapnel or any ferromagnetic material in the head
Have any active implantable medical device (e.g. pacemaker)
If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study
Concurrent enrolment in another interventional study

Interventions

DEVICEtranscranial 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.