1. A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance
- Author
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Thomas Hochadel, Antonia Periclou, J. Christopher Stein, Jonathan Rojo, Shengfang Su, Gary G. Kay, and Ramesh Boinpally
- Subjects
Adult ,Male ,Automobile Driving ,RM1-950 ,Placebo ,Article ,General Biochemistry, Genetics and Molecular Biology ,Young Adult ,Multicenter trial ,medicine ,Rapastinel ,Clinical endpoint ,Humans ,Ketamine ,General Pharmacology, Toxicology and Pharmaceutics ,Aged ,Analgesics ,Alprazolam ,business.industry ,Research ,General Neuroscience ,Articles ,General Medicine ,Middle Aged ,Antidepressive Agents ,Anti-Anxiety Agents ,Anesthesia ,NMDA receptor ,Female ,Therapeutics. Pharmacology ,Public aspects of medicine ,RA1-1270 ,Bolus (digestion) ,business ,Oligopeptides ,medicine.drug - Abstract
N‐methyl‐D‐aspartate ionotropic glutamatergic receptor (NMDAR) modulators, including rapastinel and ketamine, elicit rapid and sustained antidepressant responses in patients with treatment‐resistant major depressive disorder. This phase I, randomized, multicenter, placebo‐controlled, five‐period, crossover, single‐dose study evaluated simulated driving performance of healthy participants (N = 107) after single doses of rapastinel slow intravenous (i.v.) bolus 900 and 1800 mg, alprazolam oral 0.75 mg (positive control), ketamine i.v. infusion 0.5 mg/kg (clinical comparator), and placebo ~ 45 min before driving. The primary end point was SD of lateral position (SDLP) during the 60‐min 100‐km simulated driving scenario. Additional measures of driving performance, sleepiness, and cognition were also evaluated. To assess effects over time, mean SDLP was calculated for each 10‐min interval of driving. Sensitivity of the assays was confirmed with alprazolam (all placebo comparisons p 0.5). Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p
- Published
- 2021