Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study

• Published in: Journal of psychiatric research 2015-11, Vol.70, p.98-105
• Main Authors: Mischoulon, David, De Jong, Marasha F, Vitolo, Ottavio V, Cusin, Cristina, Dording, Christina M, Yeung, Albert S, Durham, Kelley, Parkin, Susannah R, Fava, Maurizio, Dougherty, Darin D
• Format: Article
• Language: English
• Subjects: Antidepressive Agents - therapeutic use; CES; Combined Modality Therapy - adverse effects; Combined Modality Therapy - methods; Cranial electrical stimulation; Depressive Disorder, Major - therapy; Depressive Disorder, Treatment-Resistant - therapy; Double-Blind Method; Electric Stimulation Therapy - adverse effects; Electric Stimulation Therapy - methods; Female; Humans; Major depression; Male; Middle Aged; Pilot Projects; Psychiatric Status Rating Scales; Psychiatry; Treatment Outcome; Treatment resistant depression
• ISSN: 0022-3956; 1879-1379
• DOI: 10.1016/j.jpsychires.2015.08.016

Abstract We examined efficacy and safety of one specific cranial electrical stimulator (CES) device at a fixed setting in subjects with treatment-resistant major depressive disorder (MDD). Thirty subjects (57% female, mean age 48.1 ± 12.3 years) with MDD and inadequate response to standard antidepressants were randomized to 3 weeks of treatment with CES (15/500/15,000 Hz, symmetrical rectangular biphasic current of 1–4 mAmp, 40 V) or sham CES (device off) for 20 min, 5 days per week. The primary outcome measure was improvement in the 17-item Hamilton Depression Rating Scale (HAM-D-17). Adverse effects (AEs) were assessed using the Patient Related Inventory of Side Effects (PRISE). Completion rates were 88% for CES, 100% for sham. Both treatment groups demonstrated improvement of about 3–5 points in HAM-D-17 scores (p