Status:
RECRUITING
Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
Lead Sponsor:
University of California, San Diego
Conditions:
Treatment Resistant Depression (TRD)
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-85 years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- People between the ages of 18 and 85 at the time of screening.
- Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
- Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
- 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.
- Stable internet connection and a device compatible with Microsoft Teams.
Exclusion
- History of psychotic or bipolar disorder or depression with psychotic features;
- Significant borderline personality disorder;
- Significant comorbid obsessive-compulsive or post-traumatic stress:
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
- Clinically significant suicidality disorder;
- Chronic depression (defined as of over 5 years duration);
- Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
- 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;
- Unstable medical illness;
- Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
- History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
- Require a benzodiazepine with a dose \> lorazepam 2 mg/day;
- dermatological conditions contraindicating tDCS;
- Non-correctable sensory impairments;
- Inability to consent or participate as an outpatient
Key Trial Info
Start Date :
September 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07217223
Start Date
September 27 2025
End Date
March 1 2027
Last Update
January 9 2026
Active Locations (1)
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1
UCSD Interventional Psychiatry
San Diego, California, United States, 92127