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  • Journal article
    Goodwin GM, Aaronson ST, Alvarez O, Carhart-Harris R, Chai-Rees J, Croal M, DeBattista C, Dunlop BW, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Kirlic N, Licht RW, Marwood L, Meyer TD, Mistry S, Nowakowska A, Páleníček T, Repantis D, Schoevers RA, Simmons H, Somers M, Teoh E, Tsai J, Wahba M, Williams S, Young AH, Young MB, Zisook S, Malievskaia Eet al., 2025,

    The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression.

    , J Affect Disord, Vol: 372, Pages: 523-532

    OBJECTIVE: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. METHODS: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis. RESULTS: The mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score. LIMITATIONS: The existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples. CONCLUSIONS: The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.

  • Journal article
    Jones G, Lowe MX, Nayak S, Sepeda N, Kettner H, Carhart-Harris R, Jackson H, Garcia-Romeu Aet al., 2025,

    Examining differences in the effects and contexts of naturalistic psilocybin use for White participants vs. Participants of Color: A longitudinal online survey study.

    , J Affect Disord, Vol: 370, Pages: 54-61

    BACKGROUND: Psilocybin (a psychoactive compound found in "magic mushrooms" or "shrooms") has been gaining increased attention in research and popular culture as a number of clinical and observational studies have demonstrated that it may have potential for improving mental wellbeing. Relatedly, there has been a substantial uptick in naturalistic (e.g., real-world, non-clinical) psilocybin use in the United States. While a number of longitudinal studies have demonstrated that naturalistic psilocybin use is linked to positive mental health outcomes on average, few studies have examined how the effects of psilocybin and contexts for psilocybin use may differ for White populations compared to Populations of Color. OBJECTIVE: To examine differences in health outcomes, subjective effects, and contexts of naturalistic psilocybin use in White participants compared to Participants of Color. METHODS: This study used data from a large, online longitudinal study of individuals who planned to engage in naturalistic psilocybin use (N = 2833). We used mixed-effects models to assess whether race/ethnicity (White vs. Participant of Color) moderated associations between time (Time 2 [initial assessment point for longitudinal measures], Time 5 [2-4 weeks post-psilocybin experience, and Time 6 [2-3 months post-experience]) and outcomes related to mental health (depression, anxiety, spiritual wellbeing, cognitive flexibility, emotion regulation [expressive suppression + cognitive reappraisal]). We also used exploratory chi-squared tests to examine differences in contexts for psilocybin use as well as differences in subjective effects related to the psilocybin experience. RESULTS: Race/ethnicity moderated the associations between time for predicting spiritual wellbeing (beta = -1.8; 95 % CI [-3.4, -0.17]; p < 0.05), cognitive flexibility (beta = -1.5 [-2.7, -0.26]; p < 0.05), and emotion regulation

  • Journal article
    Zeifman R, Spriggs M, Kettner H, Lyons T, Rosas F, Mediano P, Erritzoe D, Carhart-Harris Ret al., 2025,

    From Relaxed Beliefs Under Psychedelics (REBUS) to Revised Beliefs After Psychedelics (REBAS)

    , Scientific Reports, ISSN: 2045-2322

    Objectives: This was a cross sectional study aimed at describing chest x-ray findings among children hospitalised with clinically diagnosed severe pneumonia and hypoxaemia (SpO2<92%) in three tertiary facilities in Uganda.Methods: We studied chest x-rays of 375 children aged 28 days to 12 years enrolled into the Children’s Oxygen Administration Strategies Trial (COAST)(ISRCTN15622505). Radiologists blinded to the clinical findings reported chest x-rays using the standardized World Health Organization methodology for paediatric chest Xray reporting. We summarised clinical data and chest x-ray findings using descriptive statistics. Chi-square and proportion tests were used to compare proportions and quantile regression compared medians. Results: We found 172, (45.8%) children had radiological pneumonia, 136 (36.3%) normal chest radiographs while 123 (32.8%) non-pneumonia findings, the major one being cardiovascular abnormalities,106 (28.3%); 56 (14.9%) chest radiographs had both pneumonia and other abnormalities. There was no difference in the prevalence of radiological pneumonia, cardiovascular abnormalities, and mortality between the group with severe hypoxaemia (SpO2<80%) and that with mild hypoxaemia (SpO280 to <92%), (95% CI: -13.2,7.1, -6.1,15.9) and -37.2, 20.4) respectively. Conclusion: This study highlights a relatively high prevalence of cardiovascular abnormalities in children who fulfill the WHO clinical criteria for severe pneumonia and have hypoxaemia. We recommend that chest x-ray examinations be routinely done for all children in this population because information concerning cardiovascular and respiratory systems can be obtained in one sitting and guide management better. We hope that these findings can prompt discussions into refining the clinical criteria used to classify and manage pneumonia in children in limited resource settings.

  • Journal article
    Agnorelli C, Cinti A, Barillà G, Lomi F, Scoccia A, Benelli A, Neri F, Smeralda CL, Cuomo A, Santarnecchi E, Tatti E, Godfrey K, Tarantino F, Fagiolini A, Rossi Set al., 2025,

    Neurophysiological correlates of ketamine-induced dissociative state in bipolar disorder: insights from real-world clinical settings.

    , Mol Psychiatry

    Ketamine, a dissociative compound, shows promise in treating mood disorders, including treatment-resistant depression (TRD) and bipolar disorder (BD). Despite its therapeutic potential, the neurophysiological mechanisms underlying ketamine's effects are not fully understood. This study explored acute neurophysiological changes induced by subanesthetic doses of ketamine in BD patients with depression using electroencephalography (EEG) biomarkers. A cohort of 30 BD (F = 12) inpatients with TRD undergoing ketamine treatment was included in the study. EEG recordings were performed during one of the ketamine infusions with doses ranging from 0.5 to 1 mg/kg, and subjective effects were evaluated using the Clinician-Administered Dissociative States Scale (CADSS). Both rhythmic and arrhythmic features were extrapolated from the EEG signal. Patients who exhibited a clinical response to ketamine treatment within one week were classified as early responders (ER), whereas those who responded later were categorized as late responders (LR). Ketamine reduced low-frequency spectral power density while increasing gamma oscillatory power. Additionally, ketamine flattened the slope of the power spectra, indicating altered scale-free dynamics. Ketamine also increased brain signal entropy, particularly in high-frequency bands. Notably, LR exhibited greater EEG changes compared to ER, suggesting endophenotypic differences in treatment sensitivity. These findings provide valuable insights into the neurophysiological effects of ketamine in BD depression, highlighting the utility of EEG biomarkers for assessing ketamine's therapeutic mechanisms in real-world clinical settings. Understanding the neural correlates of ketamine response may contribute to personalized treatment approaches and improved management of mood disorders.

  • Journal article
    Kettner H, 2025,

    Observational cohort study of a group-based VR program to improve mental health and well-being in people with life-threatening illnesses

    , Frontiers in Virtual Reality, ISSN: 2673-4192

    Introduction. Being diagnosed with a life-threatening illness (LTI) is often accompanied by feelings of fear, uncertainty, and loneliness that can severely impact mental health. Relatively few interventions are available to address the existential concerns of individuals facing LTI, while treatment of the underlying physical ailment typically remains the priority of the healthcare system. Research has shown that psychedelic-assisted psychotherapy (PAT) holds promise for supporting mental health in people with LTIs. However, PAT’s potential in this population remains curtailed by several limitations, including regulatory and accessibility issues. Novel approaches that could provide some of the benefits of psychedelic experiences, while avoiding associated challenges, would therefore be highly desirable for supporting the mental well-being of people with LTIs. Among such interventions, VR-based experiences have been suggested as a promising candidate. We here evaluate a program that includes weakly representational, multi-user VR experiences based on a design aesthetic previously described as “numadelic”, which has been demonstrated to elicit self-transcendent experiences comparable to psychedelics.Methods. A prospective cohort study design was used to assess the effects of “Clear Light” (CL) a group-based, 6-session multimedia program that included VR experiences, video calls, and text chats spanning 3 weeks. Participants were individuals suffering from LTIs that self-selected to participate in the CL program. A total of N=15 participants were evaluated based on assessments one week before and after the program, using self-report measures of anxiety, depression, well-being, and secondary psychological outcomes.Results. The intervention was well-tolerated among participants. Significant improvements with moderate effect sizes were observed on self-reported measures of anxiety, depression, and well-being. Secondary measures assessing demor

  • Journal article
    Godfrey K, Weiss B, Zhang X, Spriggs M, Peill J, Lyons T, Carhart-Harris R, Erritzoe Det al., 2025,

    An investigation of acute physiological and psychological moderators of psychedelic-induced personality change among healthy volunteers

    , Neuroscience Applied, Vol: 4

    This study investigated the effects of a single high-dose of psilocybin on personality traits in psychedelic-naïve healthy volunteers. These data originate from a larger within-subjects fixed-order design trial, where a single high dose of psilocybin (25 mg) was administered in a psychologically supportive setting and was compared against a (one-month) prior, 1 mg ‘placebo’ dose. Personality shifts were assessed by the Big Five Inventory and the Big Five Aspect Scale, while the Altered States of Consciousness questionnaire (5D-ASC) and the Psychological Insight Scale gauged the acute psychological effects of the substance. Electroencephalography provided neurophysiological insights, specifically examining alpha power and Lempel-Ziv complexity (LZc). Results indicated significant reductions in neuroticism one month after 25 mg psilocybin administration, a finding consistent with prior studies. Reductions in neuroticism were moderated by the subjective meaningfulness of the psychedelic experience, as well as by the dread of ego dissolution subscale of the 5D-ASC, suggesting a relationship between acute drug effects and enduring personality alterations. Thus, this study substantiates the role of acute psychedelic states in catalysing lasting personality transformations in a generally beneficial direction, with broader implications for therapeutic applications and understanding of personality dynamics.

  • Journal article
    Kettner H, Roseman L, Gazzaley A, Carhart-Harris RL, Pasquini Let al., 2025,

    Reply to Letter to the Editor: "Psychedelics in Older Adults: Difficulties of a Clear Therapeutic Evidence".

    , Am J Geriatr Psychiatry, Vol: 33, Pages: 118-119
  • Journal article
    Roseman L, 2024,

    A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy.

    , J Psychopharmacol

    The recent rejection of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy by the U.S. Food and Drug Administration (FDA) is a dramatic moment in the re-emergence of psychedelic research. In this perspective, I argue that it represents a case study for paradigmatic tensions within psychopharmacology. The regulatory system is still influenced by a paradigm that sees the therapeutic effects of drugs as primarily biological, and context is noise to control for. An emergent paradigm considers the therapeutic effects of drugs as interactive with context. Psychedelics are the anomaly that questions the dominant paradigm, mainly due to the determination of psychedelic researchers that the medicines are drugs with psychotherapy. While some of the critique offered by the FDA towards MAPS/Lykos's studies is crucial, much of it is related to the experiential and psychotherapeutic elements - which the FDA claims not to regulate. This leads to some paradoxes within the regulatory procedure, which hint at a need for a shift in how psychedelic-assisted therapy is regulated and researched. Both regulators and researchers will need to find ways to accommodate each other in service of a successful integration of a new paradigm in which drugs and psychotherapy interact.

  • Journal article
    Shinozuka K, Jerotic K, Mediano P, Zhao AT, Preller KH, Carhart-Harris R, Kringelbach MLet al., 2024,

    Synergistic, multi-level understanding of psychedelics: three systematic reviews and meta-analyses of their pharmacology, neuroimaging and phenomenology

    , TRANSLATIONAL PSYCHIATRY, Vol: 14, ISSN: 2158-3188
  • Journal article
    Meshkat S, Tello-Gerez TJ, Gholaminezhad F, Dunkley BT, Reichelt AC, Erritzoe D, Veremetten E, Zhang Y, Greenshaw A, Burback L, Winkler O, Jetly R, Mayo LM, Bhat Vet al., 2024,

    Impact of psilocybin on cognitive function: A systematic review

    , PSYCHIATRY AND CLINICAL NEUROSCIENCES, Vol: 78, Pages: 744-764, ISSN: 1323-1316

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