The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder
| Autor: | Dijkstra, Francis M., van de Loo, Aurora J.A.E., Abdulahad, Smedra, Bosma, Else R., Hartog, Mitch, Huls, Hendrikje, Kuijper, Dianne C., de Vries, Esther, Solanki, Bhavna, Singh, Jaskaran, Aluisio, Leah, Zannikos, Peter, Stuurman, Frederik E., Jacobs, Gabriël E., Verster, Joris C., Afd Pharmacology, dIRAS RA-1, LS communicatie- en informatiewetenschap, One Health Toxicologie, LS IRAS Tox Algemeen, ILS L&C, Pharmacology, Institute for Risk Assesment Sciences |
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| Přispěvatelé: | Afd Pharmacology, dIRAS RA-1, LS communicatie- en informatiewetenschap, One Health Toxicologie, LS IRAS Tox Algemeen, ILS L&C, Pharmacology, Institute for Risk Assesment Sciences |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Pharmacology
Automobile Driving Depressive Disorder Major Cross-Over Studies SDLP Major depressive disorder persistent depressive disorder Antidepressive Agents Psychiatry and Mental health Double-Blind Method driving esketamine nasal spray Humans Ketamine Single-Blind Method Pharmacology (medical) Psychomotor Performance |
| Zdroj: | Journal of Psychopharmacology, 36(5), 614-625. SAGE PUBLICATIONS LTD Journal of Psychopharmacology, 36(5), 614. SAGE Publications Ltd |
| ISSN: | 0269-8811 |
| Popis: | 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 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: | OpenAIRE |
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