The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder
Francis M. Dijkstra, Aurora JAE van de Loo, Smedra Abdulahad, Else Bosma, Mitch Hartog, Hendrikje Huls, Dianne C Kuijper, Esther de Vries, Bhavna Solanki, Jaskaran Singh, Leah Aluisio, Peter Zannikos, Frederik E. Stuurman, Gabriël E. Jacobs, Joris C. Verster
Journal of Psychopharmacology February 25, 2022 DOI: 10.1177/02698811221078764 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial, cross-over study Peer reviewed |
|---|---|
| Sample size | 27 |
| Population | Patients with mild-to-moderate unipolar major depressive disorder or persistent depressive disorder without psychotic features |
| Intervention | Intranasal esketamine |
| Dose | 84 mg |
| Duration | Single dose for next-morning assessment; twice weekly for 3 weeks for same-day assessment |
| Topics | Depression Esketamine |
| Keywords | Placebo Anesthesia Mood |
| Citations | 16 |
| Key findings | Intranasal esketamine did not impair on-road driving performance the next morning after a single dose or on the same day after repeated administration over three weeks. |
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.
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.
Comparable studies
Other randomized controlled trials on esketamine for depression, most cited first.