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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCSD Interventional Psychiatry
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Interventional Psychiatry
• Email: iptrials@health.ucsd.edu
• Phone: 858-966-5832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.