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

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.

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