Authors:
N.N. Zavadenko 1 , N.Yu. Suvorinova 1 , T.T. Batysheva 2 , O.V. Bykova 2 , A.N. Platonova 2 , D.D. Gainetdinova 3 , E.V. Levitina 4 , V.V. Machines 5 , I.N. Vakula 6 , N.E. Maksimova 7
1 FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
2 GBUZ "Scientific and practical center of children's psychoneurology of the Department of Health of Moscow", Moscow, Russia;
3 FSBEI in Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia;
4 FSBEI in Tyumen State Medical University of the Ministry of Health of Russia, Tyumen, Russia;
5 FSBEI in Ulyanovsk State University, Ulyanovsk, Russia;
6 LLC "Center for Professional Therapy", Krasnodar, Russia;
7FSBEI in the Tver State Medical University, Tver, Russia
Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2022, T.122, No. 4
Summary:
Purpose of the study. Evaluate the effectiveness and safety of two dosing modes of the drug Mexidol tablets covered with a film shell, 125 mg (NPK Farmasoft LLC, Russia), compared with placebo, in children with attention deficit (ADHD) from 6 to 12 years.
Material and methods. The study conducted the study in 14 clinical centers of the Russian Federation as a multicenter randomized double blind placebo-controlled in 3 parallel groups. The study was attended by 333 children aged 6 to 12 years with a confirmed diagnosis of ADHD, established in accordance with the criteria of the ICD-10 and DSM-5. After screening (up to 14 days), patients were randomized in 3 groups in a ratio of 1: 1: 1: Mexidol 125 mg 2 times a day, Mexidol 125 mg 1 time per day+placebo and placebo. The duration of treatment in all groups was 42 days. The study was completed by 332 children. The dynamics of the state was evaluated by the scales of the ADHD assessment and related disorders.
Results. Statistically significant changes in the amount of the total score on the subx “Inattentiveness”, “Hyperactivity impulsivity” of the ADHG assessment scale through 6 weeks of therapy in all three groups of the study (P <0.05). At the same time, between the groups of Mexol 125 mg 1 time per day+placebo and placebo, as well as between Mexol groups 125 mg 2 times a day and placebo, expressed statistically significant differences were observed (for the PP: P = 0.000308 and P = 0.000024 Accordingly, for the population FAS: P = 0.000198 and P = 0.000024, respectively), which indicates the superiority of the therapy with Mexidol. According to most secondary criteria for effectiveness (average changes in points on the “Inattention” Snap-IV scale, the average change in scores “Hyperactivity impulsiveness” of the SNAP-IV scale, the average change in the cones index of the SNAP-IV scale, the average change in the value On the ADHD Rating Scale IV scale, assessments on the scale of the general clinical impression of the severity of ADHD, estimates on the general clinical impression scale - improvement) were also obtained statistically significant differences (p <0.05) when comparing the treatment of Mexido with placebo. The results of a statistical analysis of the frequency of the occurrence of undesirable phenomena, indicators of laboratory tests, and a physically examination demonstrate the absence of significant differences between compared groups in basic safety indicators.
Conclusion. The treatment regimen with Mexol, tablets covered with a film shell, 125 mg 2 times a day, showed an advantage over Mexol's scheme tablets covered with a film shell, 125 mg once a day+placebo. A comparable nature of the security profiles of the studied dosing of the drug Mexidol and placebo was obtained.
Keywords: attention deficit syndrome with hyperactivity, inattention, hyperactivity, impulsiveness, children, pharmacotherapy, ethylmethydlhydroxypyridine succinate, Mexidol.