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drugset / Trial / NCT04072354

A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

NCT04072354 ↗

Phase 3 Completed 463 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia.

Timeline

Start
2019-09-17
Primary completion
2023-05-12
Completion
2023-09-12

Outcome

Missed primary endpoint

registry Adults: Placebo vs Adults: SEP-363856 50mg; p = 0.886; Least Square (LS) Mean Difference 2.4 (95% CI -1.9 to 6.7) NCT04072354 ↗

registry Adults: Placebo vs Adults: SEP-363856 75mg; p = 0.842; LS Mean Difference -0.3 (95% CI -4.6 to 4.0) NCT04072354 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 50 mg —
Subject Ulotaront Small molecule 75 mg —

Indications

schizophrenia