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

Plain Language Summary

Simplified for easier understanding

This study tests home-based transcranial direct current stimulation (tDCS) — a gentle, non-invasive brain stimulation delivered through a wearable headset at home — as a treatment for major depressive disorder (MDD). Participants use the device at home over several weeks. **You may be eligible if...** - You are 18 or older with a current diagnosis of major depressive disorder - Your depression symptoms are at least moderate (MADRS score ≥ 18) - You are either not on antidepressants or have been on a stable dose for at least 6 weeks - You are under the care of a general practitioner (GP) - You are willing to have your GP informed about your participation **You may NOT be eligible if...** - You have significant active suicidal thoughts or plans - You have another primary psychiatric disorder (e.g., OCD) - You are currently using daily medications that affect brain excitability (like benzodiazepines) - You have heavy alcohol or illicit drug use - You have a history of epilepsy, brain surgery, or metal implants in the head Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.