Anand Ravi, Turolla Alessio, Chinellato Giovanni, Roy Arjun, Hartman Richard D
Anand Pharma Consulting AG (APC AG), St. Moritz, Switzerland.
Newron Pharmaceuticals SpA, Bresso, Italy.
Int J Neuropsychopharmacol. 2024 Dec 28;28(1). doi: 10.1093/ijnp/pyae061.
The results from a pilot, 1-year, randomized, open-label, add-on treatment study in treatment-resistant schizophrenia (TRS) with evenamide, a glutamate modulator, were not associated with any safety abnormalities at all doses (7.5-30 mg bid), with a high retention rate even at 6-month (85%), and 1-year (75%), and the absence of psychotic relapses during the 1-year treatment period. Overall, treatment with evenamide showed a gradual, sustained, and clinically important improvement up to 1 year in all efficacy measures (eg, PANSS mean change ~ -20%; CGI-S mean change ~ -1.0). In addition, compared to the results at Week 6, the responder rates generally more than doubled at 1-year (PANSS "≥20% improvement from baseline" = ~45%; CGI-S "2-category of improvement" = ~25%; CGI-C "much improved" = ~40%). These results, rarely replicated in other trials in TRS, support the use of evenamide as an add-on treatment in patients who are not benefiting from their current first- or second-generation antipsychotic medication.
一项针对难治性精神分裂症（TRS）患者开展的为期1年的先导性随机开放标签附加治疗研究结果显示，使用谷氨酸调节剂依维酰胺，在所有剂量（7.5 - 30 mg，每日两次）下均未出现任何安全性异常，即使在6个月（约85%）和1年（约75%）时仍保持较高的保留率，且在1年治疗期内未出现精神病性复发。总体而言，依维酰胺治疗在所有疗效指标上均显示出长达1年的逐渐、持续且具有临床意义的改善（例如，阳性和阴性症状量表平均变化约 -20%；临床总体印象量表严重程度平均变化约 -1.0）。此外，与第6周的结果相比，1年时的缓解率普遍增加了一倍多（阳性和阴性症状量表“较基线改善≥20%” = 约45%；临床总体印象量表严重程度“改善2级” = 约25%；临床总体印象量表疗效“显著改善” = 约40%）。这些结果在TRS的其他试验中很少重复出现，支持将依维酰胺作为附加治疗用于目前未从第一代或第二代抗精神病药物中获益的患者。
