Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant
depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians.
Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana
(Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a
serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A),
such as harmine, harmaline. The study is designed as a randomized placebo controlled trial
with two parallel arms, and it will also evaluate changes of different biomarkers of
depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum levels
of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological, psychiatric
scales and questionnaires.