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Nicole Galvão-Coelho

13 papers in the library · 341 citations · publishing 2022-2026

Papers

Default Mode Network Modulation by Psychedelics: A Systematic Review

The International Journal of Neuropsychopharmacology October 21, 2022 James J Gattuso, Daniel Perkins, Simon Ruffell et al. 233 citations

Classical psychedelics like LSD, psilocybin, and ayahuasca consistently disrupt resting-state connectivity within the Default Mode Network (DMN) and increase functional connectivity between canonical resting-state networks. The DMN, a set of brain regions active during self-referencing and mind wandering, is altered in various neuropsychiatric conditions. While DMN modulation is central to some cognitive models of psychedelics, its role in their therapeutic potential remains unclear. This systematic review provides a comprehensive overview to guide future research on the neurocognitive mechanisms of these agents.

Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression.

Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology May 1, 2025 Marcelo Falchi-Carvalho, Fernanda Palhano-Fontes, Isabel Wießner et al. 35 citations

Vaporized DMT, a short-acting psychedelic, rapidly reduced depression symptoms in patients with treatment-resistant depression. In an open-label trial, 14 patients received inhaled DMT at 15 mg and then 60 mg. The treatment was safe and well-tolerated, with no serious adverse events. By day 7, depression scores on the Montgomery-Asberg Depression Rating Scale dropped by an average of 21.14 points. The response rate was 85.71%, and the remission rate was 57.14%, with effects lasting up to 3 months. Suicidal ideation also decreased significantly, with no severe ideation the day after dosing. Vaporized DMT offers a non-invasive, time-efficient alternative to longer-acting psychedelics and traditional antidepressants.

Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology March 1, 2024 Marcelo Falchi-Carvalho, Isabel Wießner, Sérgio Ruschi B Silva et al. 25 citations

Inhaled N,N-Dimethyltryptamine (DMT) produces dose-dependent increases in the intensity, positive valence, and perceptual effects of subjective experiences, with only mild, transient, and self-limited increases in blood pressure and heart rate. No changes in safety blood biomarkers or serious adverse events occurred. The acute effects last around 10 minutes, offering a potentially cost- and time-effective alternative to longer-acting oral psychedelics for clinical use in mood disorders. This open-label, single-ascending, fixed-order, dose-response study in 27 healthy volunteers tested five dose pairs (5/20 mg through 15/60 mg) of inhaled DMT (BMND01 candidate).

Serotonergic psychedelic 5-MeO-DMT alters plasticity-related gene expression and generates anxiolytic effects in stressed mice.

Molecular Psychiatry January 1, 2025 Margareth Nogueira, Daiane C Ferreira Golbert, Richardson Menezes et al. 18 citations

A single dose of the short-acting psychedelic 5-MeO-DMT alters expression of genes related to plasticity and neuronal activity in specific brain regions of mice, including the anterior cingulate cortex, basolateral amygdala, and ventral hippocampus. Immediate early genes Arc and Zif268 changed within hours, while TRIP8b, a modulator of neuronal activity, increased in the ventral hippocampus after five days. Behaviorally, 5-MeO-DMT produced mixed anxiety-reducing and anxiety-increasing effects in standard tests, but mice pre-treated with the compound and then exposed to acute stress showed lower corticosterone levels and strong anxiety-reducing effects. The findings suggest molecular pathways through which 5-MeO-DMT may produce anxiolytic effects.

The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression.

Psychedelic medicine (New Rochelle, N.Y.) March 1, 2025 Marcelo Falchi-Carvalho, Handersson Barros, Raynara Bolcont et al. 16 citations

Vaporized N,N-dimethyltryptamine (DMT) produced rapid and sustained antidepressant effects in a small open-label trial of six people with treatment-resistant depression. Depression severity, measured by the Montgomery-Asberg depression rating scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9), decreased significantly from the first day through one month after dosing. The average MADRS score dropped by 22 points at day 7 and 17 points at one month. By day 7, 83.33% of patients responded to treatment and 66.67% achieved remission; at one month, 66.67% maintained response and 50% maintained remission. The short-acting, noninvasive vaporized route may improve accessibility to psychedelic treatments.

Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology June 17, 2025 Isabel Wießner, Marcelo Falchi-Carvalho, Sophie Laborde et al. 7 citations

Inhaled vaporized DMT (60 mg) produces profound altered states of consciousness and is safe and well-tolerated in healthy adults. In a randomized, double-blind, placebo-controlled crossover trial with 25 participants, DMT significantly increased subjective intensity and most measures on the 5D-ASC, HRS, and MEQ questionnaires compared to an active placebo (0.6 mg DMT). Physiological parameters such as blood pressure and heart rate rose transiently within safe limits. Adverse events were predominantly mild and temporary. Biochemical changes were not clinically relevant. Physiological increases correlated with subjective experiences, suggesting a link between bodily responses and the psychedelic state.

Associations Between Ayahuasca Use in Naturalistic Settings and Mental Health and Wellbeing Outcomes: Analysis of a Large Global Dataset.

Journal of Psychoactive Drugs November 23, 2024 Daniel Perkins, Jerome Sarris, Tessa Cowley-Court et al. 5 citations

People who consume ayahuasca in naturalistic settings—religious, traditional, or non-traditional—report better current mental health and greater psychological well-being, according to a large online survey of 7,576 participants from over 50 countries. More lifetime ayahuasca uses were linked to better mental health scores, and this association remained strong even after accounting for other factors and did not fade over time. Strong mystical experiences, self-insights, and community or social support were also tied to better mental health and well-being, whereas acute extreme fear during sessions and difficulty integrating the experience were linked to poorer outcomes. These patterns held for individuals both with and without a history of mental illness.

N,N-dimethyltryptamine elicits antidepressant and anxiolytic effects in helpless mice: a comparative study with S-ketamine.

Neuropharmacology July 1, 2026 Anne Nathalia De Sousa-Silva, Clarissa de Almeida Moura, Carina Ioná De Oliveira Torres et al. 1 citation

In helpless mice, the psychedelic compound N,N-dimethyltryptamine (DMT) produced rapid and long-lasting antidepressant effects comparable to the fast-acting antidepressant S-ketamine. DMT at 10 mg/kg reversed escape deficits and reduced immobility in several behavioral tests, with effects lasting up to 8 days, whereas S-ketamine's effects lasted up to 30 hours. DMT also showed anxiolytic-like effects, reversing stress-induced hypolocomotion and increasing open-arm exploration, while S-ketamine did not. Neither drug altered behavior in the novelty-suppressed feeding test. These findings suggest DMT has transdiagnostic therapeutic potential for stress-related disorders.

Mapping cognitive-behavioral approach in psychedelic-assisted treatment: a systematic review across phases with classic and non-classic psychedelics

European Archives of Psychiatry and Clinical Neuroscience March 28, 2026 Yves Martins Varela, Vagner Deuel O de Tavares, Luiza Macedo Delgado et al. 1 citation

Cognitive-behavioral therapies are being combined with psychedelic substances such as ketamine, psilocybin, and MDMA to treat mental disorders, but the way they are integrated varies widely across studies. A systematic review of 9 clinical trials involving 283 patients found that traditional cognitive behavioral therapy was the most common approach, used in 6 studies, while mindfulness-based cognitive therapy and acceptance and commitment therapy were each used in 2 and 1 studies respectively. The timing of therapy relative to the psychedelic experience—before, during, or after—also differed. The findings highlight the need for more consistent research to clarify how these therapeutic models are best implemented.

Preliminary Non-Randomized Clinical Trial of Subcutaneous Esketamine in Treatment-Resistant Depression: Exploring Adjunctive Effects of Ketamine-Assisted Psychotherapy

medRxiv Preprint Server May 31, 2026 Yves Martins Varela, Patrícia Cavalcanti-Ribeiro, Geovan Menezes de Sousa et al. preprint

Ketamine rapidly reduces depression symptoms in treatment-resistant depression, but its effects may be enhanced by combining it with psychotherapy. The drug induces neuroplasticity and psychological openness, which could help patients process emotions, restructure thoughts, and maintain improvements. However, research has not yet thoroughly examined whether adding structured psychotherapy to ketamine treatment provides additional benefits.

DMT, Madness, and Healing: Psychosis Model, Therapy Model, and Their Relations to Mystical Experiences and Positive Emotionality

Research Square May 20, 2026 Isabel Wießner, Marcelo Falchi-Carvalho, Sophie Laborde et al.

The paper explores the relationships among DMT-induced experiences, psychosis, healing, mystical experiences, and positive emotionality. It examines how DMT can serve as a model for psychosis and as a therapeutic tool, while also considering the overlap between these models and mystical experiences. The authors discuss the potential for DMT to induce states resembling psychosis but also to facilitate healing and positive emotional outcomes, suggesting that the context and set and setting are crucial in determining whether the experience leads to distress or well-being.

Acute experiences and persisting psychological effects associated with an encapsulated DMT-harmala alkaloid combination: results of a phase 1 study.

Scientific Reports November 20, 2025 Daniel Perkins, Andreas Halman, Anna Urokohara et al.

Acute subjective experiences induced by psychedelics, particularly mystical experiences, are linked to therapeutic benefits such as reduced depression, anxiety, and addiction. This study assessed a purified encapsulated DMT-harmala alkaloid product in 17 dosing sessions with 9 healthy volunteers. Strong positive correlations were found between total dose and scores on mystical experience questionnaires (MEQ-30 and SIME). The formulation reliably produced intense subjective experiences, exceeding those reported in most naturalistic ayahuasca studies, and these experiences were robustly associated with beneficial persisting psychological effects. The findings suggest this formulation warrants further clinical trials to evaluate its therapeutic potential and safety.

Ayahuasca Mitigates Morphological Cortical Alterations in Juvenile Non-human Primates Following Chronic Stress Exposure

Research Square March 5, 2025 Expedito Do Nascimento Júnior, Luiz Pereira, Wigínio Lira-Bandeira et al.

Chronic stress during adolescence can shrink neurons in the brain's somatosensory cortex, a region involved in depression. In a study of juvenile monkeys, those isolated to induce chronic stress had significantly smaller neurons than those living in a family group. However, monkeys given the traditional psychoactive brew ayahuasca before and during isolation had neuron volumes similar to the family group, suggesting the brew may protect against stress-induced cortical atrophy. Trends also hinted at preserved cortical structure in the ayahuasca-treated group, though differences in neuron density and overall cortical volume were not statistically confirmed. The findings point to ayahuasca's potential to mitigate stress-related brain changes and support further research into its therapeutic use for adolescent depression.