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Tests brain stimulation with mindfulness for adults with depression

Tests remotely given brain stimulation with mindfulness in 25 adults with depression.

Plain-language title generated from the registry record
Registry title: Transcranial Direct Current Stimulation for Depression

Key facts

Where
Woodbridge, United StatesSee the site

Where in United States

  • Soterix Medical, Inc.Woodbridge, United StatesTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Soterix Medical
Trial code
NCT07042217
Record updated
19 October 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Drug or alcohol abuse or dependence in the preceding 3 months; Concurrent benzodiazepine medication; Failure to respond to ECT treatment or rTMS treatment in this or any previous episode; Failure to respond to at least 2 antidepressant medications; 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; Implanted pump, neurostimulator, cardiac pacemaker or defibrillator; High suicide risk assessed during clinician screening at baseline interview; Metal in the cranium or skull defects; Skin lesions on scalp at the proposed electrode sites; Pregnancy.

ClinicalTrials.gov NCT07042217