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.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
January 16, 2026
Damian Swieczkowski, Aleksander Kwaśny, Krzysztof Sadko et al.
1 citation
Psilocybin-assisted therapies are being tested for major depressive disorder and treatment-resistant depression, but rigorous research requires not only measuring the drug's effects but also consistently reporting non-pharmacological factors—such as the physical and social environment (set and setting)—that can influence outcomes. To address this, the ReSPCT guidelines were developed as a 30-item framework for standardized reporting. This review evaluated 13 clinical trial protocols (11 Phase II and 2 Phase III) from ClinicalTrials.gov and the EU Clinical Trials Information System. Using the ReSPCT checklist, only 15.6% of 390 item-level assessments showed full compliance; 64.6% had partial compliance, and 19.
Journal of psychoactive drugs
April 18, 2025
Damian Swieczkowski, Aleksander Kwaśny, Krzysztof Sadko et al.
1 citation
Ibogaine, a non-classical psychedelic, is being studied as a potential treatment for substance use disorders, but safety concerns and lack of commercial interest hinder its development. A cross-sectional analysis of nine clinical trials from major registries found wide variability in trial designs, including dosing regimens and outcome measures. Most trials are early-phase, focusing on pharmacokinetics, withdrawal symptoms, and safety, with particular attention to cardiovascular risks. Preliminary evidence suggests possible therapeutic benefits, but the absence of large, late-phase trials prevents firm conclusions. Standardized clinical frameworks and lessons from research on classical psychedelics and MDMA could improve trial design and address issues like blinding and expectancy bias.