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NCT07550387

A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia

StatusCompleted
PhasePhase 2
Primary completion
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
Timeframe: Baseline and Week 6

Secondary (5)

Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=40% Change in PANSS Total Score) at Day 42
Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline
Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42
Clinical Global Impression-Improvement (CGI-I) Score at Day 42

Arms and interventions

HS-10380 Low DoseExperimental
HS-10380 Medium doseExperimental
HS-10380 High DoseExperimental
AripiprazoleActive comparator
PlaceboPlacebo comparator

Drugs: HS-10380 Low Dose, HS-10380 Medium dose, HS-10380 High Dose, Aripiprazole, Placebo

Sites

1 site in 1 country

  • Shanghai Mental Health CenterShanghai, Shanghai Municipality, China