Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)
Recruiting · NCT07228468 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
6 locations listed.
- Cardiff and Vale Health Board - Cardiff, United Kingdom
- South London and Maudsley NHS Foundation Trust - London, United Kingdom
- Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Newcastle, United Kingdom
- Northamptonshire Healthcare NHS Foundation Trust - Northampton, United Kingdom
- Nottinghamshire Healthcare NHS Foundation Trust - Nottingham, United Kingdom
- Hampshire and Isle of Wight Healthcare NHS Foundation Trust - Southampton, United Kingdom