drugset / Trial / NCT03172871
Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia
RandomizedCrossoverQuadruple-blindTreatment
Summary
This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.
Timeline
- Start
- 2017-05-15
- Primary completion
- 2019-07-22
- Completion
- 2019-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 20 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 300 mg | Intramuscular |
| Subject | Aripiprazole | Other / unclassified | 400 mg | Intramuscular |