Home-Based tDCS Treatment Of Major Depressive Disorder (NCT06976697) | Clinical Trial Compass
RecruitingNot Applicable
Home-Based tDCS Treatment Of Major Depressive Disorder
United States200 participantsStarted 2025-06-27
Plain-language summary
The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.
Who can participate
Age range
22 Years – 70 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.
In short,
Inclusion Criteria:
* 22 - 70 years of age
* Diagnosis of Unipolar MDD (DSM-V)
* PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline
* Antidepressant medication ongoing
* If in psychotherapy, have maintained stable psychotherapy
* Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+
* Be under the care of a psychiatrist or a primary care physician
* Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years
* Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence.
* Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Be willing and able to comply with all study procedures
* Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study
* Be able to understand, speak, and read English sufficient for the completion of trial assessments
Exclusion Criteria:
* Current state of mania or psychosis, or have a history of mania or psychosis.
* Treatment resistant depression.
* Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
* Be currently receiving any other interventional therapy for MDD other than…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.