Double Blinded Randomized Trial of Subcutaneous Trigeminal Nerve Stimulation as Adjuvant Treatment for Major Unipolar Depressive Disorder.

摘要: Background More than 30% of major depressive disorder patients fail to respond adequate trials medications and psychotherapy. While modern neuromodulation approaches (ie, vagal nerve stimulation, deep brain stimulation) are yet prove their efficacy for such cases in large randomized controlled trials, trigeminal stimulation (TNS) has emerged as an alternative with promising effects on mood disorders. Objective To assess efficacy, safety, tolerability, placebo effect duration continuous subcutaneous TNS (sTNS) treatment-resistant depression (TRD). Methods The TREND study is a single-center, double-blind, randomized, controlled, phase II clinical trial. Twenty unipolar TRD will receive V1 sTNS adjuvant medical therapy active vs sham throughout 24-wk period. An additional open-label follow. Data concerning response, relapse, side related surgery or electrical be recorded. We use the HDRS-17, BDI-SR, IDS_SR30, UKU scales. Expected outcomes main outcome measure improvement scores using HAM-17 under antidepressants. Active expected significantly impact response remission rates. Minor due surgical procedure stimulation. should further confirm tolerability. Discussion This protocol designed define novel TRD. must strive develop safe, reproducible, predictable, well-tolerated impaired manage lives contribute society.