Evidence map›Paper›PMID 41034820›Full record

ArticleBMC psychiatry2025

Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia.

Fang Dong, Feifei Wang, Xiaofei Yuan, Yimin Zhai, Motomichi Uki, Tao Jiang, Anning Li

2 registry-linked trialsAbstract read
In one paragraph

Article in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03285503 phase1completednot on this map

A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration

TypeinterventionalSponsorOtsuka Beijing Research InstituteRan2018 to 2019Enrolled12ConditionsSchizophreniaArmsAripiprazole IM Depot
NCT03287505 phase1completednot on this map

Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial

TypeinterventionalSponsorOtsuka Beijing Research InstituteRan2017 to 2019Enrolled24ConditionsSchizophreniaArmsAripiprazole IM Depot
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Fang DongThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China.
Feifei WangThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China.
Xiaofei YuanThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China.
Yimin ZhaiThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China.
Motomichi UkiOtsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
Tao JiangThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China. xinlingfangke01@126.com.
Anning LiThe National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders and Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital Capital Medical University, No. 5 Ankang Lane, Beijing, 100088, China. anning.li@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAripiprazole once-monthly (AOM), a long-acting injectable antipsychotic, is increasingly used in managing schizophrenia. However, to date, there has been no disclosure of pharmacokinetic data for AOM long-acting injection in the Chinese population. The present study aimed to evaluate the pharmacokinetics of AOM of Chinese patients with schizophrenia.

methodsThe single-administration part of the study was single-center and multiple-dose, in which 300/400-mg AOM was administered to 24 patients with schizophrenia. In the multiple-administration part of the study, 400-mg of AOM was administered once every 4 weeks for 20 consecutive weeks to 12 subjects. Pharmacokinetic parameters (e.g., e.g., Cmax, tmax, AUC0-∞, t1/2, and CL/F) were derived via non-compartmental analysis using actual sampling times, with bootstrap-derived confidence intervals for non-normal data. Safety evaluation included monitoring of adverse events (AEs), physical examinations, vital signs, and clinical laboratory tests.

resultsFollowing single administration of AOM (300-mg or 400-mg), maximum plasma concentration (C

conclusionsThe pharmacokinetics of AOM support its clinical use as a 4-week injectable regimen, with favorable tolerability and safety profiles observed in Chinese patients with schizophrenia.

trial registrationClinicalTrials.gov Identifier: Single-administration NCT03287505 first submitted on 15 May 2017, Multiple-administration NCT03285503 first submitted on 11 Sep 2017.

Indexed as

Antipsychotic AgentsAripiprazoleSchizophreniaAdultChinaDelayed-Action PreparationsDose-Response Relationship, DrugDrug Administration ScheduleEast Asian PeopleFemaleHumansInjections, IntramuscularMaleMiddle AgedYoung AdultAntipsychotic AgentsAripiprazoleDelayed-Action PreparationsAripiprazoleAripiprazole once-monthly (AOM)Long-acting intramuscular injectionPharmacokineticsSafetySchizophreniaTolerability

Identifiers

PMID41034820
PMCPMC12487114

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.