TY  - JOUR
PY  - 2022//
TI  - The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder
JO  - Journal of psychopharmacology
A1  - Dijkstra, Francis M.
A1  - van de Loo, Aurora Jae
A1  - Abdulahad, Smedra
A1  - Bosma, Else R.
A1  - Hartog, Mitch
A1  - Huls, Hendrikje
A1  - Kuijper, Dianne C.
A1  - de Vries, Esther
A1  - Solanki, Bhavna
A1  - Singh, Jaskaran
A1  - Aluisio, Leah
A1  - Zannikos, Peter
A1  - Stuurman, Frederik E.
A1  - Jacobs, Gabriël E.
A1  - Verster, Joris C.
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - 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>
LA  - en
SN  - 0269-8811
UR  - http://dx.doi.org/10.1177/02698811221078764
ID  - ref1
ER  -