
@article{ref1,
title="The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder",
journal="Journal of psychopharmacology",
year="2022",
author="Dijkstra, Francis M. and van de Loo, Aurora Jae and Abdulahad, Smedra and Bosma, Else R. and Hartog, Mitch and Huls, Hendrikje and Kuijper, Dianne C. and de Vries, Esther and Solanki, Bhavna and Singh, Jaskaran and Aluisio, Leah and Zannikos, Peter and Stuurman, Frederik E. and Jacobs, Gabriël E. and Verster, Joris C.",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="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. <br><br>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). <br><br>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). <br><br>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.<p /> <p>Language: en</p>",
language="en",
issn="0269-8811",
doi="10.1177/02698811221078764",
url="http://dx.doi.org/10.1177/02698811221078764"
}