Psychiatry International
September 1, 2026
Damian Swieczkowski, Michal Pruc, Lukasz Szarpak et al.
Major depressive disorder (MDD) and treatment-resistant depression (TRD) continue to drive interest in ketamine-family compounds and psilocybin, but antidepressant efficacy alone does not establish whether these interventions can be evaluated reliably or implemented responsibly. We conducted a structured narrative review using targeted PubMed/MEDLINE searches through 21 July 2026,...
International journal of psychiatry in clinical practice
June 1, 2026
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
To explore sex, racial and ethnic disparities in esketamine clinical trials for mental health disorders registered on ClinicalTrials.gov. We conducted a registry-based cross-sectional analysis of interventional esketamine trials with results posted on ClinicalTrials.gov (cut-off date: 10 February 2025). Using predefined eligibility criteria, two investigators independently extracted and...
Psychiatry Research
August 1, 2025
Damian Swieczkowski, Aleksander Kwaśny, Krzysztof Sadko et al.
5 citations
Ketamine and its enantiomers, esketamine and arketamine, have emerged as promising treatments for treatment-resistant depression (TRD). This cross-sectional study evaluates the regulatory alignment of 40 clinical trials listed on ClinicalTrials.gov, focusing on the methodological challenges. The study highlights methodological inconsistencies, particularly around the challenges of functional...
Journal of Psychopharmacology
July 11, 2025
Aleksander Kwaśny, Patrycja Ciurkowska, Wiesław Jerzy Cubała et al.
6 citations
Background: Although classic psychedelic trials show therapeutic potential, the limited diversity of participants raises concerns about generalizability and safety. Aims: This study assesses the representation of race, ethnicity, and sex in interventional clinical trials of psilocybin and lysergic acid diethylamide (LSD) to evaluate disparities in participant diversity. Methods: We conducted a...
The International Journal of Psychiatry in Medicine
April 25, 2025
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
4 citations
Objective To evaluate psilocybin's efficacy in reducing depressive and anxiety symptoms in cancer patients based on randomized controlled trials (RCTs). Methods This systematic review and network meta-analysis (NMA) followed PRISMA and Cochrane Handbook guidelines. PubMed, Embase and Cochrane Library data up to July 2024 were analyzed. Two RCTs met the inclusion criteria. Changes in Beck...
Pharmacopsychiatry
April 17, 2025
Aleksander Kwaśny, Zuzanna Gaca, Damian Swieczkowski et al.
2 citations
Abstract Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements. A cross-sectional investigation was conducted on...
Psychiatry Research
February 1, 2025
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc et al.
17 citations
Selecting the optimal dose of psilocybin for treating Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD) is crucial for clinical development and regulatory approval. This meta-analysis evaluates psilocybin's efficacy and safety in treating MDD to determine the optimal dose and timing for clinical trials. A systematic review and Dose-Response Network Meta-Analysis (NMA) of...