Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12

Summary

The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). This multicenter, prospective, double-blind, randomized trial included 333 children who met the diagnostic criteria established by the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Participants received either Mexidol or placebo for 42 days, and various efficacy and safety parameters were assessed.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)
• Anxiety Disorders and Symptoms

Interventions

DRUG

Mexidol

125 mg tablets

DRUG

Placebo

Placebo tablets

DRUG

Mexidol + Placebo

Combination of Mexidol and Placebo

Sponsors & Collaborators

• Pharmasoft

  lead INDUSTRY

Principal Investigators

• Polina S. Nikiforova, MD · State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'

• Nikolay N. Zavadenko, Dr.Med.Sci, Prof. · Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian Federation

• Olga V. Khaletskaya, Dr.Med.Sci, Prof. · Limited Liability Company "NizhMedClinic"

• Elena V. Levitina, Dr.Med.Sci, Prof. · Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation,

• Irina N. Vakula, MD · Limited Liability Company "Center for Professional Therapy"

• Olga S. Panina, Cand.Med.Sci, MD · Limited Liability Company "DNA Research Center"

• Dina D. Gainetdinova, Dr.Med.Sci, Prof. · Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation

• Anna N. Platonova, Cand.Med.Sci, MD · State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"

• Yuliya O. Boychevskaya, MD · State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory

• Natalya E. Maksimova, Cand.Med.Sci, MD · Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation

• Elena M. Kryukova, MD · State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"

• Elmira S. Sagutdinova, Cand.Med.Sci, MD · Limited Liability Company "European Medical Center 'UGMK-Health'"

• Anna S. Nezabudkina, MD · Limited Liability Company "Medical Technologies"

• Viktor V. Mashin, Dr.Med.Sci, Prof. · State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-13

Primary Completion

2020-07-13

Completion

2020-07-13

Countries

• Russia

Study Locations