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Transcranial Direct Current Stimulation for Depression

Transcranial Direct Current Stimulation for Depression

Recruiting
22 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Unipolar Depression

NCT07042217

Soterix Medical

15 October 2025

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