Publications by authors named "I N Vakula"

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.

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Aim: To assess the efficacy and safety of hopantenic acid (pantogam) compared to placebo in the treatment of attention deficit hyperactivity disorder (ADHD) in children, aged from 6 to 12 years, during 4 month in the prospective multicenter comparative double-blind placebo-controlled study in parallel groups.

Material And Methods: One hundred patients enrolled in the safety assessment population were stratified into two equal pantogam and placebo groups. Eighty-nine patients who completed the study in according to the protocol were included in the efficacy assessment group: 45 in the pantogam group and 44 in the placebo group.

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Objective: To evaluate the efficacy and tolerability of intravenous lacosamide (vimpat) in inpatients with frequent partial-onset seizures and affective and cognitive disorders.

Material And Methods: Fifteen patients were enrolled including 14 patients diagnosed with «organic personality disorder associated with epilepsy» (cryptogenic or symptomatic epilepsy with frequent partial-onset and/or secondary-generalized seizures (serial seizures in some cases) and 1 patient with a preliminary diagnosis of «organic schizophrenia-like disorder», which was changed for «organic personality disorder associated with epilepsy» after examination. Patients were treated with 2--3 antiepileptic drugs (AEDs), but no one of them received earlier lacosamide.

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Objective: To assess the efficacy and safety of children tenoten in the treatment of children and adolescents with anxiety disorders.

Material And Methods: It was conducted a multicenter, double-blind, placebo-controlled trial of the drug tenoten children at a dose of 1 tablet 3 times a day for 12 weeks. The study included 98 patients (boys and girls from 5 to 15 years with a confirmed diagnosis of anxiety disorder), randomized into two groups: the first included 48 patients treated tenotenom children, in the second - 50 patients receiving placebo.

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A group of children and adolescents with ADHD (25 boys and 9 girls), aged 6-17 years, were treated with strattera in the optimum dose (1,2 mg/day) on an outpatient basis. The assessment of treatment effectiveness showed the marked and moderately pronounced clinical effect in 78,1% patients after 3 months. The psychological study revealed a positive trend in the volume and speed of switching attention in 80% of children and the improvement of sustainability of attention - in 69%.

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