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José Carlos Bouso - One of the best experts on this subject based on the ideXlab platform.
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risk assessment of Ayahuasca use in a religious context self reported risk factors and adverse effects
Revista Brasileira de Psiquiatria, 2020Co-Authors: Icaro Durante, José Carlos Bouso, Rafael Dos G Santos, Jaime Eduardo Cecílio HallakAbstract:OBJECTIVE Whether for spiritual, recreational, or potential therapeutic use, interest in Ayahuasca has grown remarkably. Ayahuasca's main active substances are N,N-dimethyltryptamine and certain monoamine oxidase inhibitor β-carbolines. Possible drug interactions are a major concern, and research is lacking in this area. The objective of this study was to evaluate the safety of ritual Ayahuasca use regarding adverse effects and risk factors. METHODS In this cross-sectional study, Ayahuasca users from a religious institution answered an online questionnaire about its safety. Adverse effects, safety measures, and possible risk factors (psychiatric diagnosis and medications) were investigated. RESULTS The most frequent adverse effects among the 614 participants were transient gastrointestinal effects (nausea and vomiting). Fifty participants self-reported a psychiatric diagnosis (depression and anxiety were the most prevalent), and these participants experienced adverse effects more frequently. Psychiatric medication use was reported by 31 participants. No indication of increased adverse effects due to drug-drug interactions was found. CONCLUSION A minority of participants reported being very negatively affected by persistent adverse effects. Psychiatric medication use while participating in Ayahuasca rituals was not associated with increased adverse effects. For the most part, the institution's practices seem sufficient to prevent exacerbated reactions. Future studies may focus on negatively affected users.
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Effects of Ayahuasca on mental health and quality of life in naïve users: A longitudinal and cross-sectional study combination
Scientific Reports, 2020Co-Authors: Daniel F. Jiménez-garrido, Miguel Á Alcázar-córcoles, María Gómez-sousa, Rafael G. Santos, Jaime E. C. Hallak, José Carlos BousoAbstract:Ayahuasca is a hallucinogenic decoction used as a traditional medicine in several Amazonian regions. The ritualistic use of Ayahuasca has spread throughout many countries, making it necessary to study its risks and benefits. Two sub-studies were designed for this investigation. In sub-study 1, a psychiatric interview and a battery of questionnaires were administered to subjects (n = 40) before their first Ayahuasca use. Two follow-ups were conducted at 1 and 6 months. In sub-study 2, the same interview and battery of questionnaires were administered to long-term Ayahuasca users (n = 23) and their scores were compared with those of the Ayahuasca-naïve group. In the first assessment, nearly half (45%) of the naïve users were found to meet the diagnostic criteria for a psychiatric disorder. After the Ayahuasca use, more than 80% of those subjects showed clinical improvements that persisted at 6 months. The questionnaires showed significant reductions in depression and psychopathology. Regarding sub-study 2, long-term users showed lower depression scores, and higher scores for self-transcendence and quality of life, as compared to their peers in sub-study 1. Further controlled and observational naturalistic studies assessing the eventual risks and potential benefits of Ayahuasca are warranted.
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psychological variables implied in the therapeutic effect of Ayahuasca a contextual approach
Psychiatry Research-neuroimaging, 2018Co-Authors: Alba Franquesa, Joaquim Soler, Alberto Sainzcort, Sam Gandy, Miguel Angel Alcazarcorcoles, José Carlos BousoAbstract:Abstract Ayahuasca is a psychedelic decoction originating from Amazonia. The Ayahuasca-induced introspective experience has been shown to have potential benefits in the treatment of several pathologies, to protect mental health and to improve neuropsychological functions and creativity, and boost mindfulness. The underlying psychological processes related to the use of Ayahuasca in a psychotherapeutic context are not yet well described in the scientific literature, but there is some evidence to suggest that psychological variables described in psychotherapies could be useful in explaining the therapeutic effects of the brew. In this study we explore the link between Ayahuasca use and Decentering, Values and Self, comparing subjects without experience of Ayahuasca (n = 41) with subjects with experience (n = 81). Results confirm that Ayahuasca users scored higher than non-users in Decentering and Positive self, but not in Valued living, Life fulfillment, Self in social relations, Self in close relations and General self. Scores in Decentering were higher in the more experienced subjects (more than 15 occasions) than in those with less experience (less than 15 occasions). Our results show that psychological process variables may explain the outcomes in Ayahuasca psychotherapy. The introduction of these variables is warranted in future Ayahuasca therapeutic studies.
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Ayahuasca, dimethyltryptamine, and psychosis: a systematic review of human studies:
Therapeutic Advances in Psychopharmacology, 2017Co-Authors: Rafael G. Dos Santos, José Carlos Bouso, Jaime Eduardo Cecílio HallakAbstract:Ayahuasca is a hallucinogen brew traditionally used for ritual and therapeutic purposes in Northwestern Amazon. It is rich in the tryptamine hallucinogens dimethyltryptamine (DMT), which acts as a serotonin 5-HT2A agonist. This mechanism of action is similar to other compounds such as lysergic acid diethylamide (LSD) and psilocybin. The controlled use of LSD and psilocybin in experimental settings is associated with a low incidence of psychotic episodes, and population studies corroborate these findings. Both the controlled use of DMT in experimental settings and the use of Ayahuasca in experimental and ritual settings are not usually associated with psychotic episodes, but little is known regarding Ayahuasca or DMT use outside these controlled contexts. Thus, we performed a systematic review of the published case reports describing psychotic episodes associated with Ayahuasca and DMT intake. We found three case series and two case reports describing psychotic episodes associated with Ayahuasca intake, an...
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Personality, Psychopathology, Life Attitudes and Neuropsychological Performance among Ritual Users of Ayahuasca: A Longitudinal Study
2016Co-Authors: José Carlos Bouso, Marta Cutchet, Sabela Fondevila, Manuel-josé Barbanoj, Ribeiro Barbosa, Wladimyr Sena Araújo, Josep Maria Fábregas, Jordi RibaAbstract:Ayahuasca is an Amazonian psychoactive plant beverage containing the serotonergic 5-HT2A agonist N,N-dimethyltryp-tamine (DMT) and monoamine oxidase-inhibiting alkaloids (harmine, harmaline and tetrahydroharmine) that render it orally active. Ayahuasca ingestion is a central feature in several Brazilian syncretic churches that have expanded their activities to urban Brazil, Europe and North America. Members of these groups typically ingest Ayahuasca at least twice per month. Prior research has shown that acute Ayahuasca increases blood flow in prefrontal and temporal brain regions and that it elicits intense modifications in thought processes, perception and emotion. However, regular Ayahuasca use does not seem to induce the pattern of addiction-related problems that characterize drugs of abuse. To study the impact of repeate
Jaime Eduardo Cecílio Hallak - One of the best experts on this subject based on the ideXlab platform.
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risk assessment of Ayahuasca use in a religious context self reported risk factors and adverse effects
Revista Brasileira de Psiquiatria, 2020Co-Authors: Icaro Durante, José Carlos Bouso, Rafael Dos G Santos, Jaime Eduardo Cecílio HallakAbstract:OBJECTIVE Whether for spiritual, recreational, or potential therapeutic use, interest in Ayahuasca has grown remarkably. Ayahuasca's main active substances are N,N-dimethyltryptamine and certain monoamine oxidase inhibitor β-carbolines. Possible drug interactions are a major concern, and research is lacking in this area. The objective of this study was to evaluate the safety of ritual Ayahuasca use regarding adverse effects and risk factors. METHODS In this cross-sectional study, Ayahuasca users from a religious institution answered an online questionnaire about its safety. Adverse effects, safety measures, and possible risk factors (psychiatric diagnosis and medications) were investigated. RESULTS The most frequent adverse effects among the 614 participants were transient gastrointestinal effects (nausea and vomiting). Fifty participants self-reported a psychiatric diagnosis (depression and anxiety were the most prevalent), and these participants experienced adverse effects more frequently. Psychiatric medication use was reported by 31 participants. No indication of increased adverse effects due to drug-drug interactions was found. CONCLUSION A minority of participants reported being very negatively affected by persistent adverse effects. Psychiatric medication use while participating in Ayahuasca rituals was not associated with increased adverse effects. For the most part, the institution's practices seem sufficient to prevent exacerbated reactions. Future studies may focus on negatively affected users.
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well being problematic alcohol consumption and acute subjective drug effects in past year Ayahuasca users a large international self selecting online survey
Scientific Reports, 2017Co-Authors: Jaime Eduardo Cecílio Hallak, Rafael Dos G Santos, Jose Alexandre De Souza Crippa, Will Lawn, Lilla Porffy, Monica J Barratt, Jason FerrisAbstract:Ayahuasca is a natural psychedelic brew, which contains dimethyltryptamine (DMT). Its potential as a psychiatric medicine has recently been demonstrated and its non-medical use around the world appears to be growing. We aimed to investigate well-being and problematic alcohol use in Ayahuasca users, and Ayahuasca’s subjective effects. An online, self-selecting, global survey examining patterns of drug use was conducted in 2015 and 2016 (n = 96,901). Questions were asked about: use of Ayahuasca, lysergic acid diethylamide (LSD) and magic mushrooms; demographics, current well-being and past-year problematic alcohol use of past-year Ayahuasca users and comparison drug users; and subjective effects of Ayahuasca and comparison drugs. Ayahuasca users (n = 527) reported greater well-being than both classic psychedelic users (n = 18,138) and non-psychedelic drug-using respondents (n = 78,236). Ayahuasca users reported less problematic drinking than classic psychedelic users, although both groups reported greater problematic drinking than the other respondents. Ayahuasca’s acute subjective effects usually lasted for six hours and were most strongly felt one hour after consumption. Within our online, self-selecting survey, Ayahuasca users reported better well-being than comparison groups and less problematic drinking than classic psychedelic users. Future longitudinal studies of international samples and randomised controlled trials are needed to dissect the effects of Ayahuasca on these outcomes.
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Ayahuasca, dimethyltryptamine, and psychosis: a systematic review of human studies:
Therapeutic Advances in Psychopharmacology, 2017Co-Authors: Rafael G. Dos Santos, José Carlos Bouso, Jaime Eduardo Cecílio HallakAbstract:Ayahuasca is a hallucinogen brew traditionally used for ritual and therapeutic purposes in Northwestern Amazon. It is rich in the tryptamine hallucinogens dimethyltryptamine (DMT), which acts as a serotonin 5-HT2A agonist. This mechanism of action is similar to other compounds such as lysergic acid diethylamide (LSD) and psilocybin. The controlled use of LSD and psilocybin in experimental settings is associated with a low incidence of psychotic episodes, and population studies corroborate these findings. Both the controlled use of DMT in experimental settings and the use of Ayahuasca in experimental and ritual settings are not usually associated with psychotic episodes, but little is known regarding Ayahuasca or DMT use outside these controlled contexts. Thus, we performed a systematic review of the published case reports describing psychotic episodes associated with Ayahuasca and DMT intake. We found three case series and two case reports describing psychotic episodes associated with Ayahuasca intake, an...
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antidepressive and anxiolytic effects of Ayahuasca a systematic literature review of animal and human studies
Revista Brasileira de Psiquiatria, 2016Co-Authors: Rafael Dos G Santos, Flavia De Lima Osorio, Jose Alexandre De Souza Crippa, Jaime Eduardo Cecílio HallakAbstract:Objective: To conduct a systematic literature review of animal and human studies reporting anxiolytic or antidepressive effects of Ayahuasca or some of its isolated alkaloids (dimethyltryptamine, harmine, tetrahydroharmine, and harmaline). Methods: Papers published until 3 April 2015 were retrieved from the PubMed, LILACS and SciELO databases following a comprehensive search strategy and using a predetermined set of criteria for article selection. Results: Five hundred and fourteen studies were identified, of which 21 met the established criteria. Studies in animals have shown anxiolytic and antidepressive effects of Ayahuasca, harmine, and harmaline, and experimental studies in humans and mental health assessments of experienced Ayahuasca consumers also suggest that Ayahuasca is associated with reductions in anxiety and depressive symptoms. A pilot study reported rapid antidepressive effects of a single Ayahuasca dose in six patients with recurrent depression. Conclusion: Considering the need for new drugs that produce fewer adverse effects and are more effective in reducing anxiety and depression symptomatology, the described effects of Ayahuasca and its alkaloids should be further investigated.
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antidepressant effects of a single dose of Ayahuasca in patients with recurrent depression a spect study
Journal of Clinical Psychopharmacology, 2016Co-Authors: Rafael Faria Sanches, Jordi Riba, Rafael Dos G Santos, Flavia De Lima Osorio, Jose Alexandre De Souza Crippa, Ligia Ribeiro Horta De Macedo, Joao Paulo Maiadeoliveira, Lauro Wichertana, Draulio Barros De Araujo, Jaime Eduardo Cecílio HallakAbstract:Ayahuasca is an Amazonian botanical hallucinogenic brew which contains dimethyltryptamine, a 5-HT2A receptor agonist, and harmine, a monoamine-oxidase A inhibitor. Our group recently reported that Ayahuasca administration was associated with fast-acting antidepressive effects in 6 depressive patients. The objective of the present work was to assess the antidepressive potentials of Ayahuasca in a bigger sample and to investigate its effects on regional cerebral blood flow. In an open-label trial conducted in an inpatient psychiatric unit, 17 patients with recurrent depression received an oral dose of Ayahuasca (2.2 mL/kg) and were evaluated with the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, the Young Mania Rating Scale, and the Clinician Administered Dissociative States Scale during acute Ayahuasca effects and 1, 7, 14, and 21 days after drug intake. Blood perfusion was assessed eight hours after drug administration by means of single photon emission tomography. Ayahuasca administration was associated with increased psychoactivity (Clinician Administered Dissociative States Scale) and significant score decreases in depression-related scales (Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, Brief Psychiatric Rating Scale) from 80 minutes to day 21. Increased blood perfusion in the left nucleus accumbens, right insula and left subgenual area, brain regions implicated in the regulation of mood and emotions, were observed after Ayahuasca intake. Ayahuasca was well tolerated. Vomiting was the only adverse effect recorded, being reported by 47% of the volunteers. Our results suggest that Ayahuasca may have fast-acting and sustained antidepressive properties. These results should be replicated in randomized, double-blind, placebo-controlled trials.
Rafael Dos G Santos - One of the best experts on this subject based on the ideXlab platform.
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risk assessment of Ayahuasca use in a religious context self reported risk factors and adverse effects
Revista Brasileira de Psiquiatria, 2020Co-Authors: Icaro Durante, José Carlos Bouso, Rafael Dos G Santos, Jaime Eduardo Cecílio HallakAbstract:OBJECTIVE Whether for spiritual, recreational, or potential therapeutic use, interest in Ayahuasca has grown remarkably. Ayahuasca's main active substances are N,N-dimethyltryptamine and certain monoamine oxidase inhibitor β-carbolines. Possible drug interactions are a major concern, and research is lacking in this area. The objective of this study was to evaluate the safety of ritual Ayahuasca use regarding adverse effects and risk factors. METHODS In this cross-sectional study, Ayahuasca users from a religious institution answered an online questionnaire about its safety. Adverse effects, safety measures, and possible risk factors (psychiatric diagnosis and medications) were investigated. RESULTS The most frequent adverse effects among the 614 participants were transient gastrointestinal effects (nausea and vomiting). Fifty participants self-reported a psychiatric diagnosis (depression and anxiety were the most prevalent), and these participants experienced adverse effects more frequently. Psychiatric medication use was reported by 31 participants. No indication of increased adverse effects due to drug-drug interactions was found. CONCLUSION A minority of participants reported being very negatively affected by persistent adverse effects. Psychiatric medication use while participating in Ayahuasca rituals was not associated with increased adverse effects. For the most part, the institution's practices seem sufficient to prevent exacerbated reactions. Future studies may focus on negatively affected users.
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rapid antidepressant effects of the psychedelic Ayahuasca in treatment resistant depression a randomized placebo controlled trial
Psychological Medicine, 2019Co-Authors: Fernanda Palhanofontes, Heloisa Onias, Dayanna Barreto, Katia C Andrade, Flavia De Lima Osorio, Rafael Faria Sanches, Morgana M Novaes, Jessica A Pessoa, Sergio A Motarolim, Rafael Dos G SantosAbstract: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-Asberg 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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well being problematic alcohol consumption and acute subjective drug effects in past year Ayahuasca users a large international self selecting online survey
Scientific Reports, 2017Co-Authors: Jaime Eduardo Cecílio Hallak, Rafael Dos G Santos, Jose Alexandre De Souza Crippa, Will Lawn, Lilla Porffy, Monica J Barratt, Jason FerrisAbstract:Ayahuasca is a natural psychedelic brew, which contains dimethyltryptamine (DMT). Its potential as a psychiatric medicine has recently been demonstrated and its non-medical use around the world appears to be growing. We aimed to investigate well-being and problematic alcohol use in Ayahuasca users, and Ayahuasca’s subjective effects. An online, self-selecting, global survey examining patterns of drug use was conducted in 2015 and 2016 (n = 96,901). Questions were asked about: use of Ayahuasca, lysergic acid diethylamide (LSD) and magic mushrooms; demographics, current well-being and past-year problematic alcohol use of past-year Ayahuasca users and comparison drug users; and subjective effects of Ayahuasca and comparison drugs. Ayahuasca users (n = 527) reported greater well-being than both classic psychedelic users (n = 18,138) and non-psychedelic drug-using respondents (n = 78,236). Ayahuasca users reported less problematic drinking than classic psychedelic users, although both groups reported greater problematic drinking than the other respondents. Ayahuasca’s acute subjective effects usually lasted for six hours and were most strongly felt one hour after consumption. Within our online, self-selecting survey, Ayahuasca users reported better well-being than comparison groups and less problematic drinking than classic psychedelic users. Future longitudinal studies of international samples and randomised controlled trials are needed to dissect the effects of Ayahuasca on these outcomes.
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antidepressive and anxiolytic effects of Ayahuasca a systematic literature review of animal and human studies
Revista Brasileira de Psiquiatria, 2016Co-Authors: Rafael Dos G Santos, Flavia De Lima Osorio, Jose Alexandre De Souza Crippa, Jaime Eduardo Cecílio HallakAbstract:Objective: To conduct a systematic literature review of animal and human studies reporting anxiolytic or antidepressive effects of Ayahuasca or some of its isolated alkaloids (dimethyltryptamine, harmine, tetrahydroharmine, and harmaline). Methods: Papers published until 3 April 2015 were retrieved from the PubMed, LILACS and SciELO databases following a comprehensive search strategy and using a predetermined set of criteria for article selection. Results: Five hundred and fourteen studies were identified, of which 21 met the established criteria. Studies in animals have shown anxiolytic and antidepressive effects of Ayahuasca, harmine, and harmaline, and experimental studies in humans and mental health assessments of experienced Ayahuasca consumers also suggest that Ayahuasca is associated with reductions in anxiety and depressive symptoms. A pilot study reported rapid antidepressive effects of a single Ayahuasca dose in six patients with recurrent depression. Conclusion: Considering the need for new drugs that produce fewer adverse effects and are more effective in reducing anxiety and depression symptomatology, the described effects of Ayahuasca and its alkaloids should be further investigated.
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antidepressant effects of a single dose of Ayahuasca in patients with recurrent depression a spect study
Journal of Clinical Psychopharmacology, 2016Co-Authors: Rafael Faria Sanches, Jordi Riba, Rafael Dos G Santos, Flavia De Lima Osorio, Jose Alexandre De Souza Crippa, Ligia Ribeiro Horta De Macedo, Joao Paulo Maiadeoliveira, Lauro Wichertana, Draulio Barros De Araujo, Jaime Eduardo Cecílio HallakAbstract:Ayahuasca is an Amazonian botanical hallucinogenic brew which contains dimethyltryptamine, a 5-HT2A receptor agonist, and harmine, a monoamine-oxidase A inhibitor. Our group recently reported that Ayahuasca administration was associated with fast-acting antidepressive effects in 6 depressive patients. The objective of the present work was to assess the antidepressive potentials of Ayahuasca in a bigger sample and to investigate its effects on regional cerebral blood flow. In an open-label trial conducted in an inpatient psychiatric unit, 17 patients with recurrent depression received an oral dose of Ayahuasca (2.2 mL/kg) and were evaluated with the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, the Young Mania Rating Scale, and the Clinician Administered Dissociative States Scale during acute Ayahuasca effects and 1, 7, 14, and 21 days after drug intake. Blood perfusion was assessed eight hours after drug administration by means of single photon emission tomography. Ayahuasca administration was associated with increased psychoactivity (Clinician Administered Dissociative States Scale) and significant score decreases in depression-related scales (Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, Brief Psychiatric Rating Scale) from 80 minutes to day 21. Increased blood perfusion in the left nucleus accumbens, right insula and left subgenual area, brain regions implicated in the regulation of mood and emotions, were observed after Ayahuasca intake. Ayahuasca was well tolerated. Vomiting was the only adverse effect recorded, being reported by 47% of the volunteers. Our results suggest that Ayahuasca may have fast-acting and sustained antidepressive properties. These results should be replicated in randomized, double-blind, placebo-controlled trials.
Draulio B. De Araujo - One of the best experts on this subject based on the ideXlab platform.
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The psychedelic state induced by Ayahuasca modulates the activity and connectivity of the Default Mode Network
PLoS ONE, 2015Co-Authors: Fernanda Palhano-fontes, Antonio C Santos Jose, Alexandre S. Crippa, Luís Fernando Tófoli, Jaime Eduardo Cecílio Hallak, Katia C Andrade, Sidarta Ribeiro, Draulio B. De AraujoAbstract:The experiences induced by psychedelics share a wide variety of subjective features, related to the complex changes in perception and cognition induced by this class of drugs. A remarkable increase in introspection is at the core of these altered states of consciousness. Self-oriented mental activity has been consistently linked to the Default Mode Network (DMN), a set of brain regions more active during rest than during the execution of a goal-directed task. Here we used fMRI technique to inspect the DMN during the psychedelic state induced by Ayahuasca in ten experienced subjects. Ayahuasca is a potion traditionally used by Amazonian Amerindians composed by a mixture of compounds that increase monoaminergic transmission. In particular, we examined whether Ayahuasca changes the activity and connectivity of the DMN and the connection between the DMN and the task-positive network (TPN). Ayahuasca caused a significant decrease in activity through most parts of the DMN, including its most consistent hubs: the Posterior Cingulate Cortex (PCC)/Precuneus and the medial Prefrontal Cortex (mPFC). Functional connectivity within the PCC/Precuneus decreased after Ayahuasca intake. No significant change was observed in the DMN-TPN orthogonality. Altogether, our results support the notion that the altered state of consciousness induced by Ayahuasca, like those induced by psilocybin (another serotonergic psychedelic), meditation and sleep, is linked to the modulation of the activity and the connectivity of the DMN.
Katia C Andrade - One of the best experts on this subject based on the ideXlab platform.
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rapid antidepressant effects of the psychedelic Ayahuasca in treatment resistant depression a randomized placebo controlled trial
Psychological Medicine, 2019Co-Authors: Fernanda Palhanofontes, Heloisa Onias, Dayanna Barreto, Katia C Andrade, Flavia De Lima Osorio, Rafael Faria Sanches, Morgana M Novaes, Jessica A Pessoa, Sergio A Motarolim, Rafael Dos G SantosAbstract: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-Asberg 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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Rapid antidepressant effects of the psychedelic Ayahuasca in treatment-resistant depression: a randomised placebo-controlled trial
bioRxiv, 2017Co-Authors: Fernanda Palhano-fontes, J Pessoa, Flávia L. Osório, Heloisa Onias, Rafael Sanches, Dayanna Barreto, Morgana Novaes, Sergio Mota-rolim, Katia C Andrade, Rafael Dos SantosAbstract:Major Depressive Disorder affects about 350 million people worldwide, and about one-third of the patients are considered treatment-resistant. Furthermore, available antidepressants take usually two weeks for the onset of their antidepressant effect. Recent open label trials show that psychedelics, such as Ayahuasca and psilocybin, hold promise as fast-onset antidepressants. Although promising, these studies were not controlled for the placebo effect. To address this issue, and to further test the antidepressant effects of Ayahuasca, we conducted a parallel arm, double blind randomised placebo-controlled trial, in patients with treatment-resistant major depression. Thirty-five patients with treatment-resistant major depression received a single dose of Ayahuasca or placebo. We measured as primary outcome the change in the Hamilton Depression Rating scale (HAM-D) seven days after the dosing session, and as secondary outcomes the changes in Montgomery-Asberg Depression Rating Scale (MADRS), and response rates at one day (D1), two days (D2) and seven days (D7) after dosing, and remission rates at D7. This study is registered with http://clinicaltrials.gov ([NCT02914769][1]). We observed robust evidence of rapid antidepressant effects of a single dosing session with Ayahuasca when compared to placebo. HAM-D scores at D7 were significantly lower in patients treated with Ayahuasca than in those treated with placebo (p=0.019; Cohen's d=0.98). MADRS scores were significantly reduced in the Ayahuasca group compared to the placebo group at all endpoints (at D1 and D2, p=0.04; at D7, p
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The psychedelic state induced by Ayahuasca modulates the activity and connectivity of the Default Mode Network
PLoS ONE, 2015Co-Authors: Fernanda Palhano-fontes, Antonio C Santos Jose, Alexandre S. Crippa, Luís Fernando Tófoli, Jaime Eduardo Cecílio Hallak, Katia C Andrade, Sidarta Ribeiro, Draulio B. De AraujoAbstract:The experiences induced by psychedelics share a wide variety of subjective features, related to the complex changes in perception and cognition induced by this class of drugs. A remarkable increase in introspection is at the core of these altered states of consciousness. Self-oriented mental activity has been consistently linked to the Default Mode Network (DMN), a set of brain regions more active during rest than during the execution of a goal-directed task. Here we used fMRI technique to inspect the DMN during the psychedelic state induced by Ayahuasca in ten experienced subjects. Ayahuasca is a potion traditionally used by Amazonian Amerindians composed by a mixture of compounds that increase monoaminergic transmission. In particular, we examined whether Ayahuasca changes the activity and connectivity of the DMN and the connection between the DMN and the task-positive network (TPN). Ayahuasca caused a significant decrease in activity through most parts of the DMN, including its most consistent hubs: the Posterior Cingulate Cortex (PCC)/Precuneus and the medial Prefrontal Cortex (mPFC). Functional connectivity within the PCC/Precuneus decreased after Ayahuasca intake. No significant change was observed in the DMN-TPN orthogonality. Altogether, our results support the notion that the altered state of consciousness induced by Ayahuasca, like those induced by psilocybin (another serotonergic psychedelic), meditation and sleep, is linked to the modulation of the activity and the connectivity of the DMN.