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Title: Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial
Authors: Palhano-Fontes, Fernanda
Barreto, Dayanna
Onias, Heloisa
Andrade, Katia C.
Novaes, Morgana M.
Pessoa, Jessica A.
Mota-Rolim, Sergio A.
Osório, Flávia L.
Sanches, Rafael
Santos, Rafael G. dos
Tófoli, Luís Fernando
Silveira, Gabriela de Oliveira
Yonamine, Mauricio
Riba, Jordi
Santos, Francisco R.
Silva-Junior, Antonio A.
Alchieri, João C.
Galvão-Coelho, Nicole L.
Lobão-Soares, Bruno
Hallak, Jaime E. C.
Arcoverde, Emerson
Maia-de-Oliveira, João P.
Araújo, Dráulio Barros de
Keywords: Psychedelic;Hallucinogens;Banisteriopsis;Ayahuasca;Antidepressive agents;Depression;Randomized Controlled Trial (RCT);HRS;MEQ
Issue Date: 15-Jun-2018
Citation: PALHANO-FONTES et al. Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial. Psychological Medicine, [s.l], p. 1-9, jun./2018.
Portuguese Abstract: Background Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression. Methods To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing. Results We observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p = 0.04), and at D7 (p < 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen's d = 0.84; D2: Cohen's d = 0.84; D7: Cohen's d = 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64% v. 27%; p = 0.04). Remission rate showed a trend toward significance at D7 (36% v. 7%, p = 0.054). Conclusions To our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered at (NCT02914769).
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