Evidence map›Paper›PMID 39734212›Full record

Trial reportBMC psychiatry2024

Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients.

Zhen Mao, Fang Dong, Anning Li, Feng Li, Junhong Zhu, Xiangdong Du, Gang Wu, Huaili Deng, Xueqin Yu, Jintong Liu and 3 more

Abstract readMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

13 authors.

Zhen Mao *The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Fang Dong *The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Anning LiThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Feng LiThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Junhong ZhuWuhan Mental Health Center, Wuhan, 430012, China.
Xiangdong DuThe Affiliated Guangji Hospital of Soochow University, Suzhou, 215137, China.
Gang WuThe Second People's Hospital of Guizhou Province, Guizhou, 550081, China.
Huaili DengShanxi Provincial Mental Health Center, Shanxi, 030045, China.
Xueqin YuChongqing Mental Health Center, Chongqing, 400036, China.
Jintong LiuShandong Mental Health Center, Jinan, 250014, China.
Shiping XieThe Affiliated Brain Hospital of Nanjing Medical University, Nanjing, 210029, China.
Xiaowei TangAffiliated WuTaiShan Hospital of Medical College of Yangzhou University, Yangzhou, 225003, China.
Gang WangThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China. gangwangdoc@ccmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study investigates the effectiveness and safety of aripiprazole oral solution in Chinese patients with schizophrenia.

methodsThis was a multicenter, single-arm phase IV study involving 134 patients in China in the acute stage of schizophrenia from May 2021 to July 2022. The patients received aripiprazole oral solution 10 - 30 mg/d for 12 weeks. The effectiveness endpoints included the Positive and Negative Symptom Scale (PANSS) and the Clinical Global Impression (CGI) scale score. The safety endpoints included adverse events, laboratory inspection indicators (including the serum prolactin level [PRL]), and waist circumferences (WC).

resultsUltimately, 86 patients (64.18%) completed the trial, and 21 patients (15.67%) dropped out due to poor effectiveness. From baseline to week eight, 43.28% of patients had a PANSS reduction of ≥ 50%, 82.84% of patients improved in the CGI-Improvement (CGI-I scale score of 1 - 3), and the percentage of patients with abnormal PRL and waist circumferences decreased significantly. In total, 45 patients (33.58%) experienced mild adverse drug reactions predominately manifested as extrapyramidal symptoms (EPSs; 9.70%), constipation (8.96%), and palpitations (7.46%). Upon further subgroup analysis, aripiprazole oral solution demonstrated significantly improved effectiveness in first-episode schizophrenia patients and those with symptoms of agitation.

conclusionsAripiprazole oral solution displayed positive clinical effectiveness and favorable tolerability in Chinese patients in the acute stage of schizophrenia. CLINICAL

trial registrationClinical trial registration number: ChiCTR2100044653. Name of trial registration: A real-world study of Aripiprazole Oral Solution in the treatment of schizophrenia (Registration date: 25/03/2021). The full trial protocol can be accessed at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ).

Indexed as

Antipsychotic AgentsAripiprazoleSchizophreniaAdministration, OralAdultChinaEast Asian PeopleFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntipsychotic AgentsAripiprazoleAripiprazole oral solutionChineseSchizophrenia

Identifiers

PMID39734212
PMCPMC11684257

What OpenQuestion holds

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Registered trials

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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.