Current psychiatric models, while clinically valuable, remain limited in their ability to account for the complexity, variability, and context dependence of mental disorders. Converging evidence from neuroscience, complexity science, and psychedelic research suggests that psychiatric symptoms may be better understood as stable patterns of organization within dynamic, multilevel systems rather...
Clinical trials with psychedelics face several challenges that are not present to such a degree with other pharmacotherapeutics. Psychedelic therapies often include a significant therapeutic container, including preparatory and integrative psychotherapy, along with supportive intervention during dosing sessions. All these are likely to have an effect on the outcomes. Additionally, the influence...
Ketamine combined with psychotherapy has shown promise in treating posttraumatic stress disorder (PTSD), but predictors of clinical benefit remain unclear. In this systematic review and individual participant data meta-analysis (IPDMA), we examined patient- and treatment-level predictors of PTSD symptom change after combined treatment. Eligible studies combined ketamine with psychotherapy in...
Background: Job-related stress and its extreme form, burnout, continue to affect almost half of all frontline healthcare workers and first responders. Current treatments are inadequate. Objectives: To evaluate a model of ketamine-assisted psychotherapy (KAP) delivered in a group format to address symptoms of anxiety, depression, trauma, and burnout via repeated measures of the Generalized...
Introduction: Ketamine is an evidenced-based treatment for depression, and it has shown promise in addressing many other mental health conditions related to work-related stress or burnout, such as anxiety and post-traumatic stress disorder. Ketamine-assisted psychotherapy (KAP) is part of an emerging model of psychedelic medicine that employs psychoactive agents to support the psychotherapeutic...
We are experiencing a mental health crisis of unprecedented proportions. Over the last two decades this crisis grew from a perfect storm of rising insurance deductibles, escalating social stressors, the COVID-19 pandemic, and a critical workforce deficiency. Perhaps no mental health arena has a greater shortfall of effective treatment options than Post-traumatic Stress Disorder (PTSD) as the...
In the version of the article initially published, some members of the MAPP2 Study Collaborator Group were listed only in the Supplementary Information. Charlotte Harrison, Berra Yazar-Klosinski, Wael Garas, Darrick May, Cole Marta, Susan Walker, Elizabeth Nielson, Gregory Wells, Randall Brown, Revital Amiaz, Yair Wallach, Ray Worthy, Alia Lilienstein and Amy Emerson have now been added to the...
The pace of psychedelic treatments continues to increase. Regulation and coherent clinical guidance have not been established. A philosophical divide limits effective resolution of a practice delivery quandary: is this primarily a pharmacological or psychotherapeutic intervention? Lykos (formerly MAPS) has submitted its new drug application (NDA) request to the FDA for...
This study reports on 10 frontline healthcare workers, employed during the COVID-19 pandemic and experiencing symptoms of burnout and PTSD, treated with group ketamine-assisted psychotherapy (KAP) in a private outpatient clinic setting. Participants attended 6 sessions once weekly. These included 1 preparation session, 3 ketamine sessions (2 sublingual, 1 intramuscular), 2 integration sessions....
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and...
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...