The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder.

Autor: Dijkstra FM; Centre for Human Drug Research (CHDR), Leiden, The Netherlands.; Department of Psychiatry, Leiden University Medical Centre (LUMC), Leiden, The Netherlands., van de Loo AJ; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.; Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands., Abdulahad S; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands., Bosma ER; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands., Hartog M; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands., Huls H; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands., Kuijper DC; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.; Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands., de Vries E; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands., Solanki B; Janssen Research & Development, La Jolla, CA, USA., Singh J; Janssen Research & Development, La Jolla, CA, USA., Aluisio L; Janssen Research & Development, La Jolla, CA, USA., Zannikos P; Janssen Research & Development, LLC, Raritan, NJ, USA., Stuurman FE; Centre for Human Drug Research (CHDR), Leiden, The Netherlands., Jacobs GE; Centre for Human Drug Research (CHDR), Leiden, The Netherlands.; Department of Psychiatry, Leiden University Medical Centre (LUMC), Leiden, The Netherlands., Verster JC; Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands.; Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.; Centre for Human Psychopharmacology, Swinburne University, Melbourne, Australia.
Jazyk: angličtina
Zdroj: Journal of psychopharmacology (Oxford, England) [J Psychopharmacol] 2022 May; Vol. 36 (5), pp. 614-625. Date of Electronic Publication: 2022 Feb 25.
DOI: 10.1177/02698811221078764
Abstrakt: Background: Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
Aims: To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
Methods: The study consisted of two parts. Part A was a single-blind, double-dummy, randomized three-period, cross-over study to compare effects of esketamine versus placebo on next morning driving, 18 ± 2 h post-treatment. Alcohol was administered to demonstrate assay sensitivity. In Part B, same-day driving, 6 ± 0.5 hours post-treatment, was assessed during twice weekly esketamine administration for 3 weeks. Twenty-seven patients with mild-to-moderate MDD or PDD without psychotic features completed a 100 km on-the-road driving test on a public highway in normal traffic. The primary outcome was standard deviation of lateral position (SDLP; cm; weaving of car).
Results: In Part A, alcohol impaired driving performance compared to placebo: Least-square means (95% CI), p -value for delta SDLP (cm) compared with placebo: (ΔSDLP = + 1.83 (1.03; 2.62), p  < 0.001), whereas esketamine did not: (ΔSDLP = -0.23 (-1.04; 0.58), p  = 0.572). In Part B, weekly driving tests showed no differences between placebo baseline SDLP and after esketamine administration over 3 weeks: Day 11: (ΔSDLP = -0.96 (-3.72; 1.81), p  = 0.493), Day 18: (ΔSDLP = -0.56 (-3.33; 2.20), p  = 0.686) and Day 25: (ΔSDLP = -1.05 (-3.82; 1.71), p  = 0.451).
Conclusions: In this study, esketamine did not impair on-road driving performance the next morning following a single dose, or on same day after repeated administration.
Databáze: MEDLINE
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