TY - JOUR
T1 - Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression : a randomized placebo-controlled trial
AU - Palhano-Fontes, Fernanda
AU - Barreto, Dayanna
AU - Onias, Heloisa
AU - Andrade, Katia C.
AU - Novaes, Morgana M.
AU - Pessoa, Jessica A.
AU - Mota-Rolim, Sergio A.
AU - Osório, Flávia L.
AU - Sanches, Rafael
AU - dos Santos, Rafael G.
AU - Tófoli, Luís Fernando
AU - de Oliveira Silveira, Gabriela
AU - Yonamine, Mauricio
AU - Riba, Jordi
AU - Santos, Francisco R.
AU - Silva-Junior, Antonio A.
AU - Alchieri, João C.
AU - Galvão-Coelho, Nicole L.
AU - Lobão-Soares, Bruno
AU - Hallak, Jaime E. C.
AU - Arcoverde, Emerson
AU - Maia-De-Oliveira, João P.
AU - Araújo, Dráulio B.
PY - 2019
Y1 - 2019
N2 - 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 http://clinicaltrials.gov (NCT02914769).
AB - 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 http://clinicaltrials.gov (NCT02914769).
UR - https://hdl.handle.net/1959.7/uws:63665
U2 - 10.1017/S0033291718001356
DO - 10.1017/S0033291718001356
M3 - Article
SN - 0033-2917
VL - 49
SP - 655
EP - 663
JO - Psychological Medicine
JF - Psychological Medicine
IS - 4
ER -