A multicenter, placebo-controlled, randomized, double-blind, parallel-group comparison trial to investigate the efficacy and safety of brexpiprazole once-weekly (QW) formulation in patients with acute schizophrenia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500583-36-00

Acronym

331-102-00062

Enrollment

123

Registered

2023-03-03

Start date

2024-07-01

Completion date

Unknown

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Schizophrenia

Brief summary

Primary efficacy endpoint: Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6

Interventions

DRUGBrexpiprazole Fumarate-matching Placebo

DRUGRXULTI 1 mg film-coated tablets

DRUGBrexpiprazole Fumarate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6	—

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026