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Clinical Trial
. 2024 Dec 30;24(1):959.
doi: 10.1186/s12888-024-06455-y.

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

Zhen Mao #  1   2 , Fang Dong #  1   2 , Anning Li  1   2 , Feng Li  1   2 , Junhong Zhu  3 , Xiangdong Du  4 , Gang Wu  5 , Huaili Deng  6 , Xueqin Yu  7 , Jintong Liu  8 , Shiping Xie  9 , Xiaowei Tang  10 , Gang Wang  11   12
Affiliations
Clinical Trial

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

Zhen Mao et al. BMC Psychiatry. .

Abstract

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

Methods: This 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).

Results: Ultimately, 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.

Conclusions: Aripiprazole oral solution displayed positive clinical effectiveness and favorable tolerability in Chinese patients in the acute stage of schizophrenia.

Clinical trial registration: Clinical 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/ ).

Keywords: Aripiprazole oral solution; Chinese; Schizophrenia.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: All procedures of the present study were performed in accordance with the Declaration of Helsinki. The study protocols were approved by the clinical research ethics committees of Beijing Anding Hospital, Capital Medical University. All the individuals were aware of the purpose of the study and signed an informed consent form. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
a: Change of PANSS score in patients with schizophrenic who were treated with aripiprazole oral solution for 12 weeks. b: Comparison of the decrease of PANSS scores between agitated and no-agitated schizophrenia patients treated with aripiprazole oral solution for 12 weeks. c: Comparison of the decrease of PANSS scores between first-episode and chronic schizophrenia patients treated with aripiprazole oral solution for 12 weeks. d: Change of abnormal percentage of prolactin and waistline in patients with schizophrenic who were treated with aripiprazole oral solution for 12 weeks. *There is a significant difference in the PANSS score reduction from baseline (Fig. 2a). *There is a significant difference in the PANSS score reduction between the two groups (Fig. 2bcd). *P < 0.05, **P < 0.01, ***P < 0.001
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