drugset / Trial / NCT05542264

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

NCT05542264

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

Timeline

Start
2022-11-15
Primary completion
2024-02-12
Completion
2024-02-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified Oral
Comparator Olanzapine Small molecule Oral
Comparator Quetiapine Small molecule Oral
Comparator Risperidone Other / unclassified Oral
Subject Ulotaront Small molecule

Indications