Trials / Recruiting
RecruitingNCT05325645
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-34712FUM/ Brexpiprazole fumarate | 2 brexpiprazole QW tablets 24 mg (48 mg/dose) will be orally administered once weekly for 7weeks.(As an initial dose, one brexpiprazole QW tablet 24 mg and one placebo tablet will be orally administered (24 mg/dose)) |
| DRUG | Placebo | Two placebo tablets will be orally administered once weekly for 7weeks. |
Timeline
- Start date
- 2022-07-21
- Primary completion
- 2026-02-01
- Completion
- 2026-03-01
- First posted
- 2022-04-13
- Last updated
- 2025-03-12
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05325645. Inclusion in this directory is not an endorsement.