dc.contributor.author
Correll, Christoph U.
dc.contributor.author
Koblan, Kenneth S.
dc.contributor.author
Hopkins, Seth C.
dc.contributor.author
Li, Yan
dc.contributor.author
Dworak, Heather
dc.contributor.author
Goldman, Robert
dc.contributor.author
Loebel, Antony
dc.date.accessioned
2023-03-09T15:34:19Z
dc.date.available
2023-03-09T15:34:19Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/38261
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-37980
dc.description.abstract
Ulotaront, a trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors agonist, has demonstrated efficacy in the treatment of patients with an acute exacerbation of schizophrenia in a 4-week, double-blind, placebo-controlled study. The aim of this 26-week open-label extension study was to evaluate the safety and effectiveness of ulotaront (25/50/75 mg/d) in patients who completed the initial 4-week study. Of the 193 4-week completers, 157 patients (81.3%) continued into the open-label extension study; 66.9% were completers. Among all extension phase patients, treatment with ulotaront was associated with minimal changes in body weight (mean [SD] change from double-blind baseline: -0.3 [3.7] kg), cholesterol (median change, -2.0 mg/dL), triglycerides (median, -5.0 mg/dL), and prolactin (female, median, -3.4 ng/mL; male, median, -2.7 ng/mL). Movement disorder scales showed no extrapyramidal effects. Twenty-six weeks of extension phase treatment was associated with a mean (95% CI) observed change from open-label baseline in the PANSS total score of -22.6 (-25.6, -19.6; effect size, 1.46), and a mean (95% CI) change in the CGI-Severity score of -1.0 (-1.2, -0.8; effect size, 1.07). Long-term treatment with the TAAR1 agonist ulotaront, in the daily dose range of 25-75 mg, was characterized by a relatively high completion rate, an adverse event profile notable for the absence of extrapyramidal-related adverse effects, a low liability for adverse weight and metabolic effects, and no effect on prolactin levels. Additional studies are needed to further confirm the long-term efficacy and safety of ulotaront.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
schizophrenia
en
dc.subject
Ulotaront (SEP-363856
en
dc.subject
trace amine-associated receptor 1 (TAAR1)
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Safety and effectiveness of ulotaront (SEP-363856) in schizophrenia: results of a 6-month, open-label extension study
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
63
dcterms.bibliographicCitation.doi
10.1038/s41537-021-00190-z
dcterms.bibliographicCitation.journaltitle
npj Schizophrenia
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.volume
7
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
34887427
dcterms.isPartOf.eissn
2334-265X