Efficacy and Safety of Fabomotizole (AFOBAZOL® RETARD) in Patients with Adjustment Disorders Following Coronavirus Infection (COVID-19): Results of a Multicenter, Randomized, Double Blind, Placebo-Controlled Clinical Trial

Objective. To study the efficacy and safety of fabomotizole, extended-release tablets, in the treatment of adjustment disorders (AD) in patients after coronavirus infection (COVID-19). Material and methods. A double-blind, randomized, placebo-controlled clinical trial included 117 patients aged 18–55 years with AD (F43.2 according to ICD-10) of various types following COVID-19. Patients underwent a screening examination using specialized scales to assess anxiety, depression, symptom severity, and general status. Overall, 114 patients were randomized into two groups: 58 patients received fabomotizole, extended-release tablets, 30 mg (AFOBAZOL® RETARD) daily and 56 patients — placebo, 1 tablet daily, for 8 weeks. The primary efficacy endpoint was the change in the Hamilton Anxiety Rating Scale (HARS) total score at the end of the 8-week treatment period from baseline. The incidence of adverse events and safety parameters (electrocardiogram, vital signs, clinical and biochemical blood tests, C-reactive protein, urinalysis) were evaluated. Results. The change in total HARS score (the main efficacy parameter) after 8 weeks of therapy in the fabomotizole group and the placebo group was –8.2 ± 4.1 and –3.4 ± 3.7 points, respectively (p < 0.001), confirming the superiority of study drug over placebo. In the fabomotizole group, four times more patients achieved a 50 % reduction in total HARS score than in the placebo group (29.3 % vs. 7.1 %, p = 0.003). When assessing the psychopathological symptoms using other specialized scales, it was demonstrated that fabomotizole reduced the level of depression, contributed to the reduction of the severity of psychopathological symptoms and to the overall improvement of the patients’ condition. The level of brain-derived neurotrophic factor (BDNF) in the blood increased significantly during treatment, indicating a neuroprotective effect of fabomotizole. The safety profile of fabomotizole is favorable and comparable to placebo. Conclusion. Fabomotizole is an effective and safe for the treatment of AD following COVID-19 infection, with symptoms including anxiety, depression, and other neuropsychiatric disorders. © 2025 Elsevier B.V., All rights reserved.