Inserm
4 papers in the library · 17 citations · publishing 2021-2025
BMJ November 19, 2024 Cédric Lemarchand, Raphaël Chopin, M Paul et al. 9 citations
The authors identify weaknesses in the evidence regarding the efficacy and safety of hallucinogens and raise concerns about the use of expedited regulatory pathways for these substances.
BMC medicine November 28, 2025 Florian Naudet, Claude Pellen, Liviu A Fodor et al. 5 citations
Intranasal esketamine plus an antidepressant reduced depression scores by about 3 points on the MADRS scale after 4 weeks, a statistically significant but small improvement that falls below the 6.5-point threshold for clinical significance used in the pivotal trials. A continuation trial showed reduced relapse risk, but a monotherapy trial had a larger effect with concerns about bias. Esketamine increased risks of sedation, dissociation, and other adverse events without increasing serious adverse events. No moderation by age or treatment resistance level was found. The clinical relevance of the benefit is unclear given the adverse event risks.
JAMA Psychiatry April 10, 2024 Eiko I. Fried, Ioana A. Cristea, Florian Naudet 2 citations
A letter to the editor raises three concerns about a published study that tested 25 mg of psilocybin in 15 patients with treatment-resistant type 2 bipolar depression. The authors of the letter identify specific methodological issues with the study protocol but do not present new data or findings.
May 12, 2021 Ioana A. Cristea, Florian Naudet, Clara Miguel 1 citation preprint
A letter to the editor critiques the design and interpretation of a trial comparing psilocybin to escitalopram for depression, arguing that the study's conclusions may be overstated due to methodological issues such as lack of adequate blinding and potential expectancy effects. The author suggests that the reported benefits of psilocybin could be influenced by these factors, and calls for more rigorous research to confirm its efficacy relative to established treatments.