drugset / Trial / NCT03172871

Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

NCT03172871

Phase 3 Completed 436 enrolled Otsuka Beijing Research Institute
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

EvaluationDrugModalityDoseRoute
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

Indications