Qi Sufang, Li Wenjie, Yang Limin, Sun Guangwei, Li Xinming, Liu Xin, Xue Zhicheng, Zhang Yue, Xun Guanglei
Shandong Mental Health Center, Shandong University, 250014 Jinan, Shandong, China.
Alpha Psychiatry. 2025 Apr 28;26(2):40032. doi: 10.31083/AP40032. eCollection 2025 Apr.
Agitation represents a serious and prevalent symptomatology within acute schizophrenia. This study aims to conduct a nuanced comparison of the efficacy and safety profiles of intramuscular (IM) ziprasidone versus IM haloperidol in the management of agitation among patients with acute schizophrenia.
This investigation was structured as a randomized, 3-day study, utilizing flexible dosing strategies. It included 69 patients diagnosed with schizophrenia, who were randomly allocated to receive either IM ziprasidone (n = 35, 20 to 40 mg/day) or IM haloperidol (n = 34, 5 to 10 mg/day). The primary endpoints included comparative analyses of the change in Positive and Negative Syndrome Scale (PANSS) total scores and Positive and Negative Syndrome Scale Excited Component (PANSS-EC) scores from baseline to study completion across the two groups.
At baseline, there were no significant differences between the IM ziprasidone and haloperidol groups. Both treatments led to significant reductions in PANSS-EC total scores (haloperidol, = 0.001; ziprasidone, = 0.001) and PANSS total scores (haloperidol, = 0.001; ziprasidone, = 0.001) from baseline to study endpoint. Nevertheless, no significant difference was observed between the two groups in terms of changes in PANSS-EC scores ( = 0.312) and PANSS total scores ( = 0.159) from baseline to endpoint. The haloperidol group exhibited a higher incidence of adverse events compared with the ziprasidone group, reaching statistical significance ( = 0.027).
Our findings indicate that both medications are equally effective in controlling agitation symptoms. However, ziprasidone exhibited superior characteristics in safety and tolerability, particularly in reducing the incidence of extrapyramidal symptoms.
The study was registered at https://www.chictr.org.cn/showproj.html?proj=246996, registration number: ChiCTR2500100002, date of registration: 1 April 2025.
激越在急性精神分裂症中是一种严重且普遍的症状表现。本研究旨在对肌内注射齐拉西酮与肌内注射氟哌啶醇在治疗急性精神分裂症患者激越方面的疗效和安全性进行细致比较。
本研究采用灵活给药策略，设计为一项为期3天的随机研究。研究纳入69例精神分裂症患者，随机分配接受肌内注射齐拉西酮（n = 35，20至40毫克/天）或肌内注射氟哌啶醇（n = 34，5至10毫克/天）。主要终点包括对两组从基线到研究结束时阳性和阴性症状量表（PANSS）总分及阳性和阴性症状量表激越分量表（PANSS-EC）分数变化的比较分析。
在基线时，肌内注射齐拉西酮组和氟哌啶醇组之间无显著差异。从基线到研究终点，两种治疗均导致PANSS-EC总分（氟哌啶醇， = 0.001；齐拉西酮， = 0.001）和PANSS总分（氟哌啶醇， = 0.001；齐拉西酮， = 0.001）显著降低。然而，从基线到终点，两组在PANSS-EC分数变化（ = 0.312）和PANSS总分变化（ = 0.159）方面未观察到显著差异。与齐拉西酮组相比，氟哌啶醇组不良事件发生率更高，差异有统计学意义（ = 0.027）。
我们的研究结果表明，两种药物在控制激越症状方面同样有效。然而，齐拉西酮在安全性和耐受性方面表现更优，尤其是在降低锥体外系症状发生率方面。
该研究在https://www.chictr.org.cn/showproj.html?proj=246996注册，注册号：ChiCTR2500100002，注册日期：2025年4月1日。
