A Study of Olanzapine in Patients With Acute Agitation

Phase 3 Unknown 318 enrolled Qilu Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

Timeline

Start: 2023-03-28
Primary completion: 2024-05-07
Completion: 2024-07-02

Publications

Dong F, Wang Z, Li C, Li X, Zhu D, Li J, Wang Z, Gong J, Zhou J, Liu H, Zhang Y, Zhang X, Chen X, Yu M, Tan X, Qian M, Luo Y, Guo WJ, Xie S, Huang J, Zhao J, Wan J, Shan Y, Li N, Wang J, Ju Y, Wang J, Bian Q, Wang G. Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3 Multicenter, Randomized, Double-Blind, Active-Controlled Trial. Drug Des Devel Ther. 2026 Feb 25;20:561494. doi: 10.2147/DDDT.S561494. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Haloperidol	Other / unclassified	7.5 mg	Intramuscular
Subject	Olanzapine	Small molecule	10 mg	Intramuscular

Indications

No indication recorded.