Shi Hui, Xu Jing, Lang Xiaoe, Wu Hanjing Emily, Xiu Mei Hong, Zhang Xiang Yang
Department of Psychiatry, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Qingdao Mental Health Center, Qingdao Medical University, Qingdao, China.
Front Pharmacol. 2022 Apr 26;13:863588. doi: 10.3389/fphar.2022.863588. eCollection 2022.
Treatment-resistant schizophrenia (TRS) is a prevalent clinical problem with heterogeneous presentations. However, the clinical trial designs for new treatments are still lacking. This study aimed to assess the efficacy of ziprasidone plus sertraline in TRS patients as compared to ziprasidone monotherapy. We conducted a 24 weeks, randomized, controlled, double-blinded clinical research trial. 62 treatment-resistant patients with acute exacerbation SZ were randomly allocated to receive a usual dose of ziprasidone (120-160 mg/d) monotherapy (Control group) and 53 TRS inpatients were to receive a low dose of ziprasidone (60-80 mg/d) in combination with sertraline (ZS group). Treatment outcomes were measured by the Positive and Negative Syndrome Scale (PANSS), the Hamilton Depression Rating Scale (HAMD), CGI-Severity (CGI-S) and Personal and Social Performance Scale (PSP) at baseline, week 4, 8, 12, and 24. Relative to control group, the patients in ZS group showed greater reductions in the following: PANSS positive symptom, negative symptom, total score, and HAMD total score. Additionally, the patients in ZS group had a greater increase in PSP total score. Notably, the reduction in HAMD was positively correlated with the reduction in PANSS total score. The reduction in CGI-S was a predictor for the improvement of psychosocial functioning in patients. Furthermore, the ZS group had a lower rate of side effects compared to the control group. Our findings suggest that a low dose of ziprasidone in combination with sertraline is an effective therapy for the clinical symptoms as compared to a usual dose of ziprasidone in the treatment-resistant patients with acute exacerbation SZ. ClinicalTrials.gov, identifier NCT04076371.
难治性精神分裂症（TRS）是一个临床表现多样的普遍临床问题。然而，针对新治疗方法的临床试验设计仍很缺乏。本研究旨在评估与齐拉西酮单药治疗相比，齐拉西酮联合舍曲林对TRS患者的疗效。我们进行了一项为期24周的随机、对照、双盲临床研究试验。62例急性加重期难治性精神分裂症患者被随机分配接受常规剂量的齐拉西酮（120 - 160毫克/天）单药治疗（对照组），53例TRS住院患者接受低剂量的齐拉西酮（60 - 80毫克/天）联合舍曲林治疗（ZS组）。在基线、第4周、第8周、第12周和第24周，通过阳性和阴性症状量表（PANSS）、汉密尔顿抑郁量表（HAMD）、临床总体印象严重程度量表（CGI - S）和个人及社会功能量表（PSP）来测量治疗结果。与对照组相比，ZS组患者在以下方面有更大程度的降低：PANSS阳性症状、阴性症状、总分以及HAMD总分。此外，ZS组患者的PSP总分有更大程度的提高。值得注意的是，HAMD的降低与PANSS总分的降低呈正相关。CGI - S的降低是患者心理社会功能改善的一个预测指标。此外，ZS组的副作用发生率低于对照组。我们的研究结果表明，与常规剂量的齐拉西酮相比，低剂量的齐拉西酮联合舍曲林对急性加重期难治性精神分裂症患者的临床症状是一种有效的治疗方法。ClinicalTrials.gov标识符：NCT04076371。
