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Transcranial Direct Current Stimulation for Depression
Recruiting
A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder
Who can join
Ages 22 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview * Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression * QIDS-SR score \>11 on all three days of screening week (Days 1,3, 7) * Scored at least 17 (inclusive) on the HDRS-17 at trial entry * Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening * Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential. Exclusion Criteria: * Failure to respond to at least 2 antidepressant medications * Drug or alcohol abuse or dependence in the preceding 3 months * Concurrent benzodiazepine medication * High suicide risk assessed during clinician screening at baseline interview. * Failure to respond to ECT treatment or rTMS treatment in this or any previous episode. * Current DSM-V-TR psychotic disorder * History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician * Metal in the cranium or skull defects * Implanted pump, neurostimulator, cardiac pacemaker or defibrillator * Skin lesions on scalp at the proposed electrode sites * Pregnancy
About the study
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.
What is being tested
- transcranial direct current stimulation (tDCS) and mindfulness instruction (device)
- Sham tDCS and Mindfulness (device)
Sponsor: Soterix Medical · Participants: 25 · Started: Jul 1, 2025
Contact the study team
- Paul Thomas Researcher · Phone: 18889908327
Official record on ClinicalTrials.gov — NCT07042217
Locations in the U.S.
| New Jersey | Soterix Medical, Inc., Woodbridge |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.