Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with
antidepressant drugs, which are limited for issues such as refractoriness and adverse
effects. In this context, the investigators investigate a non-pharmacological treatment known
as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective
than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is
virtually absent of adverse effects. Its ease of use, portability and low price are also
interesting characteristics for using in primary and secondary health care. Thus, our aim is
to compare tDCS against a fully dosed, effective antidepressant. The study will be a
non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing
active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our
primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a
noninferiority margin of at least 50% of the escitalopram-placebo effect.
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo
Collaborators:
Brain & Behavior Research Foundation Fundação de Amparo à Pesquisa do Estado de São Paulo