NCT07228468 Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)
| NCT ID | NCT07228468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 438 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 438 participants in total. It began in 2025-11-18 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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
Contact & Investigator
Cynthia Fu, MD, PhD
PRINCIPAL INVESTIGATOR
King's College London
Frequently Asked Questions
Who can join the NCT07228468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07228468 currently recruiting?
Yes, NCT07228468 is actively recruiting participants. Contact the research team at cynthia.fu@kcl.ac.uk for enrollment information.
Where is the NCT07228468 trial being conducted?
This trial is being conducted at Cardiff, United Kingdom, London, United Kingdom, Newcastle, United Kingdom, Northampton, United Kingdom and 2 additional locations.
Who is sponsoring the NCT07228468 clinical trial?
NCT07228468 is sponsored by King's College London. The principal investigator is Cynthia Fu, MD, PhD at King's College London. The trial plans to enroll 438 participants.