Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

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

Outcome

Met primary endpoint

paper The non-inferiority of AOM to oral aripiprazole was established, with comparable efficacy and tolerability. PMID 34989824 ↗

paper The non-inferiority margin of AOM to oral aripiprazole was - 4.1, which was above the lower limit of the pre-defined margin. PMID 34989824 ↗

Publications

• Xiao L, Zhao Q, Li AN, Sun J, Wu B, Wang L, Zhang H, Zhang R, Li K, Xu X, Liu T, Zhang W, Xie S, Xu X, Tan Y, Zhang K, Zhang H, Guan N, Xian M, Uki M, Wang G. Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study. Psychopharmacology (Berl). 2022 Jan;239(1):243-251. doi: 10.1007/s00213-021-06044-x. Epub 2022 Jan 6.

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

Indications