Major Depression Clinical Trials

Find Major Depression Clinical Trials Near You

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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Cardiff and Vale Health Board
NOT_YET_RECRUITING
Cardiff
South London and Maudsley NHS Foundation Trust
RECRUITING
London
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
NOT_YET_RECRUITING
Newcastle
Northamptonshire Healthcare NHS Foundation Trust
NOT_YET_RECRUITING
Northampton
Nottinghamshire Healthcare NHS Foundation Trust
NOT_YET_RECRUITING
Nottingham
Hampshire and Isle of Wight Healthcare NHS Foundation Trust
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Cynthia Fu
cynthia.fu@kcl.ac.uk
020 7848 0002
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 438
Treatments
No_intervention: Treatment as usual (TAU)
Treatment as usual will consist of standard care, such as psychotherapy and/or antidepressant medication or no treatment, as decided by participant and treating clinician.
Experimental: transcranial direct current stimulation + treatment as usual (tDCS + TAU)
In addition to receiving treatment as usual, participants randomized to receive tDCS will engage in a 10-week treatment protocol of active tDCS which participants will administer at home. Stimulation schedule is 5 sessions per week for 3 weeks followed by 3 sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS device is headset with bifrontal montage, anode at left dorsolateral prefrontal cortex (DLPFC) and cathode at right DLPFC (EEG positions F3 and F4, respectively). Stimulation is 2 mA for 30 minutes with a gradual ramp up over 30 seconds. Electrode area is 23 cm2.
Related Therapeutic Areas
Sponsors
Collaborators: Northumberland, Tyne and Wear NHS Foundation Trust, Northamptonshire Healthcare NHS Foundation Trust, Cardiff and Vale University Health Board, Nottinghamshire Healthcare NHS Trust, Southern Health NHS Foundation Trust, South London and Maudsley NHS Foundation Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov