Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients
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...
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2024-12-01
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| Series: | BMC Psychiatry |
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| Online Access: | https://doi.org/10.1186/s12888-024-06455-y |
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| author | Zhen Mao Fang Dong Anning Li Feng Li Junhong Zhu Xiangdong Du Gang Wu Huaili Deng Xueqin Yu Jintong Liu Shiping Xie Xiaowei Tang Gang Wang |
| author_facet | Zhen Mao Fang Dong Anning Li Feng Li Junhong Zhu Xiangdong Du Gang Wu Huaili Deng Xueqin Yu Jintong Liu Shiping Xie Xiaowei Tang Gang Wang |
| author_sort | Zhen Mao |
| collection | DOAJ |
| description | 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/ ). |
| format | Article |
| id | doaj-art-76c70ff544f94ee3a863bc3e64374f14 |
| institution | Kabale University |
| issn | 1471-244X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj-art-76c70ff544f94ee3a863bc3e64374f142025-01-05T12:42:48ZengBMCBMC Psychiatry1471-244X2024-12-0124111010.1186/s12888-024-06455-yEffectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patientsZhen Mao0Fang Dong1Anning Li2Feng Li3Junhong Zhu4Xiangdong Du5Gang Wu6Huaili Deng7Xueqin Yu8Jintong Liu9Shiping Xie10Xiaowei Tang11Gang Wang12The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityWuhan Mental Health CenterThe Affiliated Guangji Hospital of Soochow UniversityThe Second People’s Hospital of Guizhou ProvinceShanxi Provincial Mental Health CenterChongqing Mental Health CenterShandong Mental Health CenterThe Affiliated Brain Hospital of Nanjing Medical UniversityAffiliated WuTaiShan Hospital of Medical College of Yangzhou UniversityThe National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical UniversityAbstract 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/ ).https://doi.org/10.1186/s12888-024-06455-yAripiprazole oral solutionChineseSchizophrenia |
| spellingShingle | Zhen Mao Fang Dong Anning Li Feng Li Junhong Zhu Xiangdong Du Gang Wu Huaili Deng Xueqin Yu Jintong Liu Shiping Xie Xiaowei Tang Gang Wang Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients BMC Psychiatry Aripiprazole oral solution Chinese Schizophrenia |
| title | Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients |
| title_full | Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients |
| title_fullStr | Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients |
| title_full_unstemmed | Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients |
| title_short | Effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in Chinese patients |
| title_sort | effectiveness and safety of aripiprazole oral solution in the acute treatment of schizophrenia in chinese patients |
| topic | Aripiprazole oral solution Chinese Schizophrenia |
| url | https://doi.org/10.1186/s12888-024-06455-y |
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