drugset / Trial / NCT01033084
Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Phase 2/3
Completed
120 enrolled
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-12
- Completion
- 2011-12
Outcome
Met primary endpoint
paper At the main end point, there was a significant difference in Montgomery-Asberg depression rating scale scores PMID 23389323 ↗
paper the combined treatment group (sertraline/active tDCS) vs sertraline only (mean difference, 8.5 points; 95% CI, 2.96 to 14.03; P = .002) PMID 23389323 ↗
paper In MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. PMID 23389323 ↗
Publications
- Background Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Vieira GP, Bueno VF, Goulart AC, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011 Jan;32(1):90-8. doi: 10.1016/j.cct.2010.09.007. Epub 2010 Sep 18.
- Background Alessandra Baccaro, Andre Russowsky Brunoni, Isabela Martins Bensenor, Felipe Fregni. Hypomanic episode in unipolar depression during transcranial direct current stimulation. Acta Neuropsychiatrica 22(6):316-318, 2010.
- Brunoni AR, Kemp AH, Dantas EM, Goulart AC, Nunes MA, Boggio PS, Mill JG, Lotufo PA, Fregni F, Bensenor IM. Heart rate variability is a trait marker of major depressive disorder: evidence from the sertraline vs. electric current therapy to treat depression clinical study. Int J Neuropsychopharmacol. 2013 Oct;16(9):1937-49. doi: 10.1017/S1461145713000497. Epub 2013 Jun 12.
- Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 50 mg | — |