[Results of a multicentre double-blind randomised placebo-controlled clinical trial evaluating the efficacy and safety of Mexidol in the treatment of Attention Deficit Hyperactivity Disorder in Children (MEGA)].

Autor:	Zavadenko NN; Pirogov Russian National Research Medical University, Moscow, Russia., Suvorinova NY; Pirogov Russian National Research Medical University, Moscow, Russia., Batysheva TT; Scientific Research and Practical Center of Pediatric Psychoneurology, Moscow, Russia., Bykova OV; Scientific Research and Practical Center of Pediatric Psychoneurology, Moscow, Russia., Platonova AN; Scientific Research and Practical Center of Pediatric Psychoneurology, Moscow, Russia., Gaynetdinova DD; Kazan State Medical University, Kazan, Russia., Levitina EV; Tyumen State Medical University, Tyumen, Russia., Mashin VV; Ulyanovsk State University, Ulyanovsk, Russia., Vakula IN; Center of professional therapy, Krasnodar, Russia., Maximova NE; Tver State Medical University, Tver, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2022; Vol. 122 (4), pp. 75-86.
DOI:	10.17116/jnevro202212204175
Abstrakt:	Objectives: To evaluate the efficacy and safety of two dosing regimens of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT» LLC Russia), compared with placebo in children with attention deficit hyperactivity disorder (ADHD) aged 6 to 12 years. Material and Methods: A multicenter randomized, double-blind, placebo-controlled study in 3 parallel groups was conducted in 14 clinical centres of the Russian Federation to assess efficacy and safety of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT» LLC Russia) in the treatment of attention deficit hyperactivity disorder (ADHD) in children 6-12 years old with different dosing regimens. The study involved 333 boys and girls aged 6 to 12 years with a confirmed diagnosis of ADHD established in accordance with ICD-10 and DSM-5 criteria. After screening (up to 14 days) the patients were randomised into 3 treatment groups in a 1:1:1: Mexidol 125 mg 2 times daily, Mexidol 125 mg daily+placebo and the placebo group. The duration of treatment in all groups was 42 days. 332 children completed the study. ADHD and comorbid disorders assessment scales were used. Results: There were statistically significant changes in the sum of the total scores on the SNAP-IV inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy in all three study groups ( p <0.05). There were statistically significant differences between the Mexidol 125 mg and placebo groups and between the Mexidol 125 mg 2 times daily and placebo groups (for the PP population: p =0.000308 and p =0.000024, respectively; for the FAS population: p =0.000198 and p =0.000024, respectively), indicating that Mexidol therapy is superior to placebo. Statistically significant differences ( p< 0.05) were also obtained for most of the secondary efficacy criteria (average change in SNAP-IV inattention subscale score, average change in SNAP-IV hyperactivity/impulsivity subscale score, average change in SNAP-IV subscale score - Conners index, average change in ADHD-RS-IV score, change in CGI-ADHD-S scores, change in CGI-I score - the Clinical Global Impressions Scale - Improvement) when comparing Mexidol therapy with placebo. The results of statistical analysis of the incidence of adverse events, laboratory values, physical examination show no significant differences between the compared groups in the main safety parameters. Conclusions: The regimen of Mexidol, 125 mg film-coated tablets twice daily has been shown to be superior to the regimen of Mexidol, 125 mg film-coated tablets once daily and placebo. The safety profiles of the studied dosing regimens of Mexidol and placebo were comparable.
Databáze:	MEDLINE
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