Smulevich A B, Ivanov S V, Yakhin K K, Voronova E I, Kharkova G S, Skurygina E I, Konohova M V, Beybalaeva T Z, Katok A A
Mental Health Research Centre, Moscow, Russia.
Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(12):67-72. doi: 10.17116/jnevro202012012167.
Currently available antipsychotics have limited efficacy in the treatment of negative symptoms in schizophrenia and new drugs with wider spectrums of clinical efficacy are very desirable. Cariprazine is a newer antipsychotic acting as dopamine D3- and in lesser extent D2-receptor partial agonist found to be effective in the treatment of negative symptoms in schizophrenia.
To evaluate cariprazine early effects at the first stage of therapy of schizophrenia patients with predominantly negative symptoms.
Open-lable observational assessment of 60 adult schizophrenia patients (F20 on ICD-10, 49% males) with predominantly negative symptoms (PANSS-FSNS ≥15, PANSS-FSPS <19) treated by cariprazine (starting daily dose 1.5 mg followed by upward titration by 1.5 mg weekly up to 6 mg if needed) were assessed with PANSS, CAINS, CDSS and SAS scales at baseline and on week 1, 2, and 4. Efficacy criteria were.
Most patients (75%) improved during 28 days of cariprazine treatment. Negative symptoms mean total scores on PANSS-NS and CAINS significantly (<0.05) reduced by 4.3 and 4.9 respectively at the end of assessment (day 28). Cariprazine tolerability was good, only 4 patients discontinued because of TEAEs (akathisia, insomnia).
The study results preliminary suggest initial effect of cariprazine on negative symptoms at least in some schizophrenia patients with predominantly negative symptoms starting from 1-2 weeks of treatment and available for observation and assessment and could be useful for determination of early clinical predictors for efficacy. Considering limitations of observational open-lable design with no control groups these data need to be confirmed.
目前可用的抗精神病药物在治疗精神分裂症的阴性症状方面疗效有限，因此非常需要具有更广泛临床疗效的新药。卡立哌嗪是一种新型抗精神病药物，作为多巴胺D3受体部分激动剂，在较小程度上也是D2受体部分激动剂，已发现其对治疗精神分裂症的阴性症状有效。
评估卡立哌嗪对以阴性症状为主的精神分裂症患者治疗第一阶段的早期疗效。
对60例以阴性症状为主（ICD-10编码为F20，男性占49%，阳性和阴性症状量表-阴性症状总分≥15，阳性和阴性症状量表-阳性症状总分<19）的成年精神分裂症患者进行开放标签观察性评估，患者接受卡立哌嗪治疗（起始日剂量1.5mg，必要时每周向上滴定1.5mg，直至6mg），在基线以及第1、2和4周时使用阳性和阴性症状量表、临床总体印象-阴性症状量表、临床总体印象-严重程度量表和焦虑自评量表进行评估。疗效标准如下。
大多数患者（75%）在卡立哌嗪治疗的28天内病情改善。在评估结束时（第28天），阳性和阴性症状量表-阴性症状及临床总体印象-阴性症状量表的阴性症状平均总分分别显著降低（<0.05）4.3分和4.9分。卡立哌嗪耐受性良好，仅有4例患者因治疗中出现的不良反应（静坐不能、失眠）停药。
研究结果初步表明，卡立哌嗪至少对部分以阴性症状为主的精神分裂症患者的阴性症状有早期疗效，从治疗1 - 2周起即可观察和评估，这可能有助于确定疗效的早期临床预测指标。考虑到无对照组的开放标签观察性设计的局限性，这些数据需要进一步证实。
