Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives.

Abstract

BACKGROUND:

Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with tools of non-invasive brain stimulation - such as transcranial magnetic stimulation and transcranial direct current stimulation (tDCS). Due to its profile, tDCS seems to be a safe and affordable approach.

METHODS AND DESIGN:

The SELECT TDCS trial aims to compare sertraline vs. tDCS in a double-blinded, randomized, factorial trial enrolling 120 participants to be allocated to four groups to receive sertraline+tDCS, sertraline, tDCS or placebo. Eligibility criteria are moderate-to-severe unipolar depression (Hamilton Depression Rating Scale >17) not currently on sertraline treatment. Treatment will last 6weeks and the primary outcome is depression change in the Montgomery-Asberg Depression Rating Score (MADRS). Potential biological markers that mediate response, such as BDNF serum levels, Val66Met BDNF polymorphism, and heart rate variability will also be examined. A neuropsychological battery with a focus on executive functioning will be administered.

DISCUSSION:

With this design we will be able to investigate whether tDCS is more effective than placebo in a sample of patients free of antidepressants and in addition, we will be able to secondarily compare the effect sizes of sertraline vs. tDCS and also the comparison between tDCS and combination of tDCS and sertraline.

• Authors: Andre Russowsky Brunoni, Leandro Valiengo, Alessandra Baccaro, Tamires Araujo Zanao, Janaina Farias de Oliveira, Giselly Pereira Vieira, Viviane Freire Bueno, Alessandra C Goulart, Paulo Sérgio Boggio, Paulo Andrade Lotufo, Isabela Martins Bensenor, Felipe Fregni
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 32 Issue 1 Pg. 90-8 (Jan 2011) ISSN: 1559-2030 [Electronic] United States
• PMID: 20854930 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Inc. All rights reserved.

Chemical References

• Antidepressive Agents
• Sertraline

Topics

• Antidepressive Agents (therapeutic use)
• Cerebral Cortex (physiology, physiopathology)
• Clinical Protocols
• Combined Modality Therapy
• Depressive Disorder, Major (drug therapy, physiopathology, therapy)
• Double-Blind Method
• Electric Stimulation Therapy (methods)
• Humans
• Research Design
• Sertraline (therapeutic use)
• Treatment Outcome