Last reviewed · How we verify
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
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
Details
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 450 |
| Start date | 2022-07-21 |
| Completion | 2026-03 |
Conditions
- Acute Schizophrenia
Interventions
- OPC-34712FUM/ Brexpiprazole fumarate
- Placebo
Primary outcomes
- Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period — Baseline and Week 7
Countries
Japan