Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRN |
Texto Completo: | https://repositorio.ufrn.br/jspui/handle/123456789/25439 https://doi.org/10.1017/S0033291718001356 |
Resumo: | 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). |
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Palhano-Fontes, FernandaBarreto, DayannaOnias, HeloisaAndrade, Katia C.Novaes, Morgana M.Pessoa, Jessica A.Mota-Rolim, Sergio A.Osório, Flávia L.Sanches, RafaelSantos, Rafael G. dosTófoli, Luís FernandoSilveira, Gabriela de OliveiraYonamine, MauricioRiba, JordiSantos, Francisco R.Silva-Junior, Antonio A.Alchieri, João C.Galvão-Coelho, Nicole L.Lobão-Soares, BrunoHallak, Jaime E. C.Arcoverde, EmersonMaia-de-Oliveira, João P.Araújo, Dráulio Barros de2018-06-18T12:58:27Z2018-06-18T12:58:27Z2018-06-15PALHANO-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.https://repositorio.ufrn.br/jspui/handle/123456789/25439https://doi.org/10.1017/S0033291718001356engPsychedelicHallucinogensBanisteriopsisAyahuascaAntidepressive agentsDepressionRandomized Controlled Trial (RCT)HRSMEQRapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleBackground 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).info:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRNinstname:Universidade Federal do Rio Grande do Norte (UFRN)instacron:UFRNORIGINALDraulioAraujo_ICe_rapid antidepressant effects_2018.pdfDraulioAraujo_ICe_rapid antidepressant effects_2018.pdfDraulioAraujo_ICe_rapid antidepressant effects_2018application/pdf388807https://repositorio.ufrn.br/bitstream/123456789/25439/1/DraulioAraujo_ICe_rapid%20antidepressant%20effects_2018.pdf894a53683a51cfac370ebbd9af774c4fMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://repositorio.ufrn.br/bitstream/123456789/25439/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD52TEXTDraulioAraujo_ICe_rapid antidepressant effects_2018.pdf.txtDraulioAraujo_ICe_rapid antidepressant effects_2018.pdf.txtExtracted texttext/plain55618https://repositorio.ufrn.br/bitstream/123456789/25439/3/DraulioAraujo_ICe_rapid%20antidepressant%20effects_2018.pdf.txtf0869185e3f72a6e57baa7c774ef4e00MD53THUMBNAILDraulioAraujo_ICe_rapid antidepressant effects_2018.pdf.jpgDraulioAraujo_ICe_rapid antidepressant effects_2018.pdf.jpgIM Thumbnailimage/jpeg9607https://repositorio.ufrn.br/bitstream/123456789/25439/4/DraulioAraujo_ICe_rapid%20antidepressant%20effects_2018.pdf.jpg6e6092dcbcaf8570c9e2f6d71c1f5937MD54123456789/254392021-07-08 15:23:27.58oai:https://repositorio.ufrn.br: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Repositório de PublicaçõesPUBhttp://repositorio.ufrn.br/oai/opendoar:2021-07-08T18:23:27Repositório Institucional da UFRN - Universidade Federal do Rio Grande do Norte (UFRN)false |
dc.title.pt_BR.fl_str_mv |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
title |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
spellingShingle |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial Palhano-Fontes, Fernanda Psychedelic Hallucinogens Banisteriopsis Ayahuasca Antidepressive agents Depression Randomized Controlled Trial (RCT) HRS MEQ |
title_short |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
title_full |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
title_fullStr |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
title_full_unstemmed |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
title_sort |
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial |
author |
Palhano-Fontes, Fernanda |
author_facet |
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 |
author_role |
author |
author2 |
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 |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
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 |
dc.subject.por.fl_str_mv |
Psychedelic Hallucinogens Banisteriopsis Ayahuasca Antidepressive agents Depression Randomized Controlled Trial (RCT) HRS MEQ |
topic |
Psychedelic Hallucinogens Banisteriopsis Ayahuasca Antidepressive agents Depression Randomized Controlled Trial (RCT) HRS MEQ |
description |
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). |
publishDate |
2018 |
dc.date.accessioned.fl_str_mv |
2018-06-18T12:58:27Z |
dc.date.available.fl_str_mv |
2018-06-18T12:58:27Z |
dc.date.issued.fl_str_mv |
2018-06-15 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
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. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufrn.br/jspui/handle/123456789/25439 |
dc.identifier.doi.none.fl_str_mv |
https://doi.org/10.1017/S0033291718001356 |
identifier_str_mv |
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. |
url |
https://repositorio.ufrn.br/jspui/handle/123456789/25439 https://doi.org/10.1017/S0033291718001356 |
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eng |
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