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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
View on ClinicalTrials.gov →
NCT07042217
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
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Actively Recruiting
PhaseN/A
SponsorSoterix Medical
Started2025-07-01
Est. completion2026-09-01
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07042217