At-home spaced transcranial direct current stimulation for treatment-resistant depression

Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study

This will test whether a two-week program of at-home spaced transcranial direct current stimulation (tDCS) can help people with treatment-resistant depression who have not improved on antidepressants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT07217223 on ClinicalTrials.gov

What this trial studies

This single-arm, open-label feasibility and safety study asks participants with treatment-resistant major depressive disorder to self-administer tDCS at home under live remote supervision. Treatment is delivered over two weeks with weekday sessions consisting of five 20-minute stimulations each day, spaced by ~20-minute intervals for about three hours daily. Pre- and post-treatment neurophysiological biomarker sessions and clinical mood measures are collected, and four required in-person appointments occur at UCSD in San Diego. The study will track safety, tolerability, feasibility of home delivery, and changes in mood and brain activity before, during, and after the intervention.

Who should consider this trial

Good fit: Adults aged 18–85 with diagnosed major depressive disorder and MADRS ≥20 who have a documented inadequate response to antidepressant treatment (ATHF ≥3 or at least two inadequate/intolerant trials), are safe for TMS, and have a stable internet connection and compatible device are ideal candidates.

Not a fit: People with a history of bipolar disorder, psychosis, significant borderline personality disorder, major comorbid OCD/PTSD, current moderate-to-severe substance use disorder, or those unable to attend four in-person visits in San Diego or lacking reliable internet/device access are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, this could offer an effective, lower-burden home treatment option for people whose depression has not responded to standard antidepressants.

How similar studies have performed: Prior tDCS studies for depression and some small home-based tDCS programs have shown mixed but promising results for symptom improvement and feasibility, though the intensive spaced multi-session daily protocol is relatively novel.

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

Where this trial is running

San Diego, California

• UCSD Interventional Psychiatry — San Diego, California, United States (Recruiting)

Study contacts

• Study coordinator: Interventional Psychiatry

Conditions Treatment Resistant Depression; Major Depressive Disorder; Treatment; MDD