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Recruiting NCT07228468

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

Trial Parameters

Condition Major Depressive Disorder (MDD)
Sponsor King's College London
Study Type INTERVENTIONAL
Phase N/A
Enrollment 438
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-18
Completion 2027-05-15
Interventions
transcranial direct current stimulation (tDCS)

Brief 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 Criteria

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

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