Actively Recruiting
Transcranial Direct Current Stimulation for Depression
Led by Soterix Medical · Updated on 2025-11-10
25
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
CONDITIONS
Official Title
Transcranial Direct Current Stimulation for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically stable patients diagnosed with major depressive disorder (MDD) according to DSM-V-TR confirmed with Mini International Neuropsychiatric interview
- Currently experiencing a major depressive episode lasting at least 4 weeks as part of unipolar depression
- QIDS-SR score greater than 11 on all three screening days (Days 1, 3, 7)
- Score of at least 17 on the HDRS-17 depression scale at trial entry
- Stable antidepressant medication for at least 30 days prior to HDRS-17 screening
- Female participants must not be pregnant and use medically acceptable contraception if of childbearing potential
You will not qualify if you...
- Failure to respond to at least 2 antidepressant medications
- Drug or alcohol abuse or dependence within the past 3 months
- Current use of benzodiazepine medication
- High suicide risk assessed at baseline
- Failure to respond to electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) in this or any previous episode
- Current psychotic disorder according to DSM-V-TR
- History of neurological disorder or injury affecting study participation as determined by study physician
- Presence of metal in skull or skull defects
- Implanted devices such as pump, neurostimulator, pacemaker, or defibrillator
- Skin lesions on the scalp at electrode sites
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Soterix Medical, Inc.
Woodbridge, New Jersey, United States, 07095
Actively Recruiting
Research Team
P
Paul Thomas Researcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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