NYMC Faculty Publications
Efficacy of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From Three 5-Week, Randomized, Double-Blind, Placebo-Controlled, EMERGENT Trials
Author Type(s)
Faculty
DOI
10.1038/s41537-024-00525-6
Journal Title
Schizophrenia
Document Type
Article
Publication Date
12-1-2024
Department
Psychiatry and Behavioral Sciences
Disciplines
Medicine and Health Sciences
Abstract
In the 5-week, randomized, double-blind, placebo-controlled EMERGENT-1 (NCT03697252), EMERGENT-2 (NCT04659161), and EMERGENT-3 (NCT04738123) trials, xanomeline and trospium chloride (formerly known as KarXT) significantly improved symptoms of schizophrenia and was generally well tolerated. We pooled data from the EMERGENT trials to further characterize the efficacy of xanomeline/trospium and provide sufficient statistical power to analyze responses in participant subgroups. In pooled analyses, xanomeline/trospium significantly improved Positive and Negative Syndrome Scale (PANSS) total score at week 5 versus placebo (least squares mean difference, –9.9; 95% confidence interval, –12.4, –7.3; p < 0.0001; Cohen’s d effect size, 0.65). PANSS subscale and Clinical Global Impression–Severity scores also improved significantly with xanomeline/trospium versus placebo. Subgroup analyses consistently favored xanomeline/trospium over placebo regardless of differences in participant age, sex, race, body mass index, and baseline PANSS total score. These results add to existing evidence demonstrating robust and reliable improvements in symptoms with xanomeline/trospium across a broad spectrum of people with schizophrenia.
Recommended Citation
Kaul, I., Sawchak, S., Claxton, A., Sauder, C., Hassman, H., Kakar, R., Walling, D., Citrome, L., Zhu, H., Miller, A., & Brannan, S. (2024). Efficacy of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From Three 5-Week, Randomized, Double-Blind, Placebo-Controlled, EMERGENT Trials. Schizophrenia, 10 (1). https://doi.org/10.1038/s41537-024-00525-6
