Psychiatry research
February 1, 2025
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
17 citations
In patients with Major Depressive Disorder, psilocybin reduces depression symptoms more than placebo by Day 8 and Day 15 after treatment, but not by Day 2. A 25 mg dose is the most effective among those tested (0.215 mg/kg, 10 mg, and 25 mg). Psilocybin carries a higher risk of adverse events, especially nausea. These findings come from a meta-analysis of three randomized placebo-controlled trials involving 389 adults.
Journal of Psychopharmacology
July 11, 2025
Aleksander Kwaśny, Patrycja Ciurkowska, Wiesław Jerzy Cubała et al.
6 citations
In interventional clinical trials of psilocybin and LSD, participants are overwhelmingly White, raising concerns about whether these therapies are safe and effective for diverse populations. A cross-sectional analysis of nine eligible trials (eight psilocybin, one LSD) registered on ClinicalTrials.gov through January 2025 found that among 501 psilocybin participants, 87.2% were White, 3.0% Black, and 5.0% Asian; ethnicity was reported in only four trials, with 13.4% identifying as Hispanic or Latino. The single LSD trial of 11 older adults reported no race or origin data. Participation-to-population ratios for U.S.-only trials confirmed underrepresentation of Black and Asian individuals. The authors conclude that broader recruitment and standardized reporting are essential to ensure equity and establish safety and efficacy across groups.
Psychiatry research
August 1, 2025
Damian Swieczkowski, Aleksander Kwaśny, Krzysztof Sadko et al.
5 citations
A cross-sectional evaluation of 40 clinical trials on ketamine and its enantiomers, esketamine and arketamine, for treatment-resistant depression reveals significant methodological inconsistencies. Key issues include inadequate blinding due to ketamine's dissociative effects, poor management of expectancy bias, and insufficient safety monitoring. Placebo response, accounting for a large portion of treatment effects, was inconsistently handled, and long-term follow-up was lacking in most trials, limiting understanding of extended safety. The findings call for harmonized, rigorous frameworks to improve regulatory approval and therapeutic success, with lessons applicable to other psychedelics under investigation for mental health disorders.
The International Journal of Psychiatry in Medicine
April 25, 2025
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
4 citations
Psilocybin rapidly reduced depressive and anxiety symptoms in cancer patients, though the effect on depression was not sustained at two weeks. Based on two randomized controlled trials, a network meta-analysis found that Beck Depression Inventory scores improved one day after administration but not at follow-up. State anxiety scores showed substantial reductions both at one day and two weeks; trait anxiety scores also improved at both time points. The highest dose tested (0.3 mg/kg) was the most effective. The small number of trials limits confidence in the findings, and larger, high-quality studies are needed.
Pharmacopsychiatry
April 17, 2025
Aleksander Kwaśny, Zuzanna Gaca, Damian Swieczkowski et al.
2 citations
Regulatory compliance in clinical trials of psilocybin for major depressive disorder and treatment-resistant depression shows gaps. A review of four trial protocols from ClinicalTrials.gov found that while they superficially met regulatory requirements, they inadequately addressed drug interactions, concurrent antidepressant use, and prohibited medications. Functional unblinding and expectancy bias were not fully accounted for. Risk mitigation relied on external criteria. Patients with bipolar or schizoaffective disorders were excluded. The most common psilocybin dose studied was 25 mg. Two trials were double-blind. The findings underscore the need for stricter adherence to regulatory standards in psychedelic clinical research and for exploring efficacy in broader populations.
International journal of psychiatry in clinical practice
June 1, 2026
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
Women made up 62.9% of participants across 13 esketamine clinical trials for mental health disorders, while men comprised 37.1%. The racial distribution showed White participants at 69.08%, Asian at 13.31%, Black or African American at 3.60%, American Indian or Alaska Native at 0.08%, and Native Hawaiian or Other Pacific Islander at 0.04%. Hispanic or Latino representation ranged from 10.57% to 11.02% due to reporting discrepancies in one trial. These trials demonstrate significant racial and ethnic disparities, with underrepresentation of minority groups, highlighting the need for regulatory efforts to improve diversity and fair representation in future research.