NCT07217223 Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
| NCT ID | NCT07217223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Treatment Resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-27 |
| Primary Completion | 2026-10-01 |
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 10 participants in total. It began in 2025-09-27 with a primary completion date of 2026-10-01.
⚠ 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
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies. PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.
Eligibility Criteria
Inclusion Criteria: 1. People between the ages of 18 and 85 at the time of screening. 2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20. 3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS). 4. Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition. 5. Stable internet connection and a device compatible with Microsoft Teams. Exclusion Criteria: 1. History of psychotic or bipolar disorder or depression with psychotic features; 2. Significant borderline personality disorder; 3. Significant comorbid obsessive-compulsive or post-traumatic stress: 4. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal; 5. Clinically significant suicidality disorder; 6. Chronic depression (defined as of over 5 years duration); 7. Pregnancy or lactation, lack of adequate birth control in women of childbearing age; 8. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms; 9. Unstable medical illness; 10. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion); 11. History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response; 12. Require a benzodiazepine with a dose \> lorazepam 2 mg/day; 13. dermatological conditions contraindicating tDCS; 14. Non-correctable sensory impairments; 15. Inability to consent or participate as an outpatient
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07217223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Treatment Resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07217223 currently recruiting?
Yes, NCT07217223 is actively recruiting participants. Contact the research team at iptrials@health.ucsd.edu for enrollment information.
Where is the NCT07217223 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT07217223 clinical trial?
NCT07217223 is sponsored by University of California, San Diego. The trial plans to enroll 10 participants.
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