鼻内注射艾氯胺酮可迅速改善抑郁症状。然而,短暂的不良反应(解离,镇静和头晕)可能会发生,这可能会影响驾驶性能。
评估84mg鼻内艾氯胺酮对单相重度抑郁症(MDD)或持续性抑郁症(PDD)患者驾驶表现的影响。
本研究由两部分组成。A部分是单盲的,双假人,随机三期,交叉研究,以比较艾司氯胺酮与安慰剂对第二天早上驾驶的影响,治疗后18±2小时。施用酒精以证明测定灵敏度。在B部分,当天开车,治疗后6±0.5小时,在每周两次给予艾氯胺酮3周内进行评估。27名没有精神病特征的轻度至中度MDD或PDD患者在正常交通的公共高速公路上完成了100公里的道路驾驶测试。主要结果是横向位置的标准偏差(SDLP;cm;汽车编织)。
在A部分中,与安慰剂相比,酒精损害驾驶表现:最小二乘均值(95%CI),与安慰剂相比,deltaSDLP(cm)的p值:(ΔSDLP=1.83(1.03;2.62),p<0.001),而艾氯胺酮没有:(ΔSDLP=-0.23(-1.04;0.58),p=0.572)。在B部分,每周驾驶测试显示安慰剂基线SDLP与给予艾氯胺酮3周后无差异:第11天:(ΔSDLP=-0.96(-3.72;1.81),p=0.493),第18天:(ΔSDLP=-0.56(-3.33;2.20),p=0.686)和第25天:(ΔSDLP=-1.05(-3.82;1.71),p=0.451)。
在这项研究中,单剂量服用后第二天早上,艾氯胺酮没有损害公路驾驶性能,或在重复给药后的同一天。
Intranasal esketamine demonstrates rapid improvement of depressive symptoms. However, transient adverse effects (dissociation, sedation and dizziness) may occur, which could impact driving performance.
To evaluate the effects of 84 mg intranasal esketamine on driving performance in unipolar major depressive disorder (MDD) or persistent depressive disorder (PDD) patients.
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).
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).
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.