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)

N.N. Zavadenko

Pirogov Russian National Research Medical University

ORCID: 0000-0003-0103-7422

N.Yu. Suvorinova

Pirogov Russian National Research Medical University

T.T. Batysheva

Scientific Practical Center of Pediatric Psychoneurology of the Department of Heath Care of Moscow

SPIN RSCI: 2364-1600
Scopus AuthorID: 16051959600
ORCID: 0000-0003-0928-2131

O.V. Bykova

Research and Clinical Centre of Pediatric Psychoneurology Moscow Department of Public Health;
Medical Institute of the Peoples' Friendship University of Russia

SPIN RSCI: 9134-8597
Scopus AuthorID: 6603610307
ORCID: 0000-0001-6576-1765

A.N. Platonova

Scientific Research and Practical Center of Pediatric Psychoneurology

D.D. Gaynetdinova

Kazan State Medical University

E.V. Levitina

Tyumen State Medical University

V.V. Mashin

Ulyanovsk State University

ORCID: 0000-0003-0085-3727

I.N. Vakula

State Budgetary Healthcare Institution «Specialized Clinical Psychiatric Hospital No. 1»

N.E. Maksimova

Tver State Medical University

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2022;122(4): 75–86

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)

Authors:

N.N. Zavadenko, N.Yu. Suvorinova, T.T. Batysheva, O.V. Bykova, A.N. Platonova, D.D. Gaynetdinova, E.V. Levitina, V.V. Mashin, I.N. Vakula, N.E. Maksimova

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DOI: 10.17116/jnevro202212204175

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Zavadenko NN, Suvorinova NYu, Batysheva TT, Bykova OV, Platonova AN, Gaynetdinova DD, Levitina EV, Mashin VV, Vakula IN, Maksimova NE. 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). S.S. Korsakov Journal of Neurology and Psychiatry. 2022;122(4):75‑86. (In Russ., In Engl.).
https://doi.org/10.17116/jnevro202212204175

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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.

Keywords:

attention deficit hyperactivity disorder

ethylmethylhydroxypyridine succinate

Mexidol

Authors:

N.N. Zavadenko

Pirogov Russian National Research Medical University

ORCID: 0000-0003-0103-7422

N.Yu. Suvorinova

Pirogov Russian National Research Medical University

T.T. Batysheva

Scientific Practical Center of Pediatric Psychoneurology of the Department of Heath Care of Moscow

SPIN RSCI: 2364-1600
Scopus AuthorID: 16051959600
ORCID: 0000-0003-0928-2131

O.V. Bykova

Research and Clinical Centre of Pediatric Psychoneurology Moscow Department of Public Health;
Medical Institute of the Peoples' Friendship University of Russia

SPIN RSCI: 9134-8597
Scopus AuthorID: 6603610307
ORCID: 0000-0001-6576-1765

A.N. Platonova

Scientific Research and Practical Center of Pediatric Psychoneurology

D.D. Gaynetdinova

Kazan State Medical University

E.V. Levitina

Tyumen State Medical University

V.V. Mashin

Ulyanovsk State University

ORCID: 0000-0003-0085-3727

I.N. Vakula

State Budgetary Healthcare Institution «Specialized Clinical Psychiatric Hospital No. 1»

N.E. Maksimova

Tver State Medical University

Received:

01.03.2022

Accepted:

18.03.2022

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