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Clinical Trials in the USA / NCT07042217
Recruiting Not applicable

Transcranial Direct Current Stimulation for Depression

NCT07042217 · tracked via the Priya Life Science USA tracker
Sponsor
Soterix Medical
Phase
Not applicable
Started
2025-07-01
Last updated
2025-11-10

Condition(s) studied

Unipolar Depression

Investigational drug(s) / intervention(s)

transcranial direct current stimulation (tDCS) and mindfulness instructionSham tDCS and Mindfulness

transcranial direct current stimulation (tDCS) and mindfulness instruction: tDCS together with audio providing mindfulness instruction and music

Sham tDCS and Mindfulness: Placebo electrical sitmulation and audio-guided mindfulness instruction

Study 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

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Soterix Medical, Inc. Woodbridge New Jersey Recruiting

More Soterix Medical trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07042217 on ClinicalTrials.gov ↗ ← All trials in the USA