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Transcranial Direct Current Stimulation for Depression

RECRUITINGN/ASponsored by Soterix Medical
Actively Recruiting
PhaseN/A
SponsorSoterix Medical
Started2025-07-01
Est. completion2026-09-01
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 22 Years+Healthy volunteers accepted
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

Conditions2

DepressionUnipolar Depression

Locations1 site

Soterix Medical, Inc.
Woodbridge, New Jersey, 07095
Paul Thomas18889908327trials@soterixmedical.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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