drugset / Trial / NCT03198078
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Phase 3
Completed
316 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
Timeline
- Start
- 2017-06-30
- Primary completion
- 2023-04-03
- Completion
- 2023-04-03
Outcome
Met primary endpoint
registry analysis (superiority test); Brexpiprazole vs Placebo; p = 0.0136; LS mean difference -5.33 (95% CI -9.55 to -1.10) NCT03198078 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Comparator | Aripiprazole | Other / unclassified | 15 mg | Oral |
| Comparator | Aripiprazole | Other / unclassified | 20 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 4 mg | Oral |