RecruitingNot ApplicableNCT07042217

Transcranial Direct Current Stimulation for Depression

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

Sponsor

Soterix Medical

Enrollment

25 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Unipolar Depression

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

Min Age: 22 Years

Inclusion Criteria6

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 Criteria11

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