EEG Prediction and Clinical Efficacy of tDCS in Major Depression (NCT07611773) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EEG Prediction and Clinical Efficacy of tDCS in Major Depression
Spain270 participantsStarted 2026-06-01
Plain-language summary
The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression.
As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years or over.
* Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).
* Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).
* Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.
* Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.
* Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.
* Have the ability and willingness to commit to the study team to complete all phases of the study.
* Volunteer to participate and sign the specific informed consent form for this study.
Exclusion Criteria:
* Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.
* Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.
* Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses tDCS, which is a form of brain stimulation — how does that work, and how does it compare to antidepressants or therapy options I might already be considering for my major depressive disorder?
2The trial is listed as 'not yet recruiting' — do you know when it's expected to open, and is it worth waiting for, or should we be pursuing other treatments in the meantime?
3The study is measuring depression severity using something called the HDRS-17 scale — can you explain what that measures and what kind of improvement would actually be meaningful for my day-to-day life?
4Since this trial doesn't have a listed phase, what does that tell us about how much safety and effectiveness data already exists for tDCS in major depression, and are there any risks I should understand before considering it?
5Would I be a good candidate to discuss this trial with my care team, and are there other tDCS or brain stimulation studies that are already actively enrolling that might be worth looking at alongside this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HDRS-17
Timeframe: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).