Skip to content

Lukasz Szarpak

Department of Clinical Research and Development, LUXMED Group, Warsaw, Poland; Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States; Research Unit, Maria Sklodowska-Curie Bialystok Oncology Center, Bialystok, Poland; Institute of Medical Science, Collegium Medicum, The John Paul II Catholic University of Lublin, Lublin, Poland.

4 papers in the library · 26 citations · publishing 2025-2026

Papers

Efficacy and safety of psilocybin in the treatment of Major Depressive Disorder (MDD): A dose-response network meta-analysis of randomized placebo-controlled clinical trials.

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.

Lessons learned from the regulatory alignment in ketamine, esketamine and arketamine clinical trials: A cross-sectional analysis of protocols from ClinicalTrials.gov.

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.

Psilocybin-assisted psychotherapy as a rapid-acting treatment for cancer-related depression and anxiety: Evidence from a network meta-analysis

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.

Addressing diversity gaps in esketamine clinical trials: a registry-based cross-sectional analysis of sex, race and ethnicity.

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.