Objective: To evaluate the efficacy and safety of pregabalin as adjunctive treatment for children (aged 1 month-<4 years) with focal onset seizures (FOS) using videoelectroencephalography (V-EEG). Methods: This randomized, placebo-controlled, international study included V-EEG seizure monitoring (48-72 hours) at baseline and over the last 3 days of 14-day (5-day dose escalation; 9-day fixed dose) double-blind pregabalin treatment (7 or 14 mg/kg/d in three divided doses). This was followed by a double-blind 1-week taper. The primary efficacy endpoint was log-transformed seizure rate (log e [24-hour seizure rate + 1]) for all FOS recorded during the double-blind V-EEG monitoring, evaluated in subjects who took ≥1 dose of study medication, experienced ≥1 baseline seizure(s), and had a treatment phase V-EEG. Safety and tolerability were assessed by adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms. Results: Overall, 175 patients were randomized (mean age = 28.2 months; 59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7 or 14 mg/kg/d (n = 71 or n = 34, respectively), or placebo (n = 70). Pregabalin 14 mg/kg/d (n = 28) resulted in a statistically significant 35% reduction of log e (24-hour seizure rate + 1) versus placebo (n = 53; P = .022), an effect that was not observed with pregabalin 7 mg/kg/d (n = 59; P = .461). The most frequently reported treatment-emergent AEs for pregabalin 7 mg/kg/d, 14 mg/kg/d, and placebo, respectively, were somnolence (11.3%, 17.6%, and 5.7%) and upper respiratory tract infection (7.0%, 11.8%, and 11.4%). All AEs were mild to moderate in severity. |MANN et Al.

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The article studys the psychological characteristics in patients with brain tumors of different localization which allows to reduce the diagnostic period and, as a result, minimize the time of early detection and the consequences of the surgical treatment of this pathology, and to cause a positive effect on preventing the development of psychopathological disorders at the hospital stage. Analysis of the clinical manifestations of depressive disorders of the subclinical level revealed their polymorphism: depression was accompanied by various variants of asthenic (prevalence of dyssomnias, psychalgia, adynamia and anxiety component) and anxiety (prevalence of senestopathies, hypochondria, phobia) states. The revealed symptom complexes of psychopathological and pathopsychological characteristics of the patient's condition were the clinical justification for the choice of methods of psychotherapeutic correction. Adjuvant psycho­logical therapy, individual rational and family psychotherapy were used as the basic method of psycho­therapeutic influence. Pharmacological correction included: anxiolytics, antidepressants, atypical mild antipsychotics in low doses. The results of the SCL-90-R test demonstrate the effectiveness of the comprehensive treatment aimed at preventing and reducing the manifestations of psychopathological symptoms. Comparison of the mean values of the SCL-90-R test revealed significant differences in such indicators as somatization (p<0.05), depressiveness (p<0.01), anxiety (p<0.05); high statistical significance is noted in the “index of symptom severity” integral indicator (p<0.01). Obtained results of psychological and psychiatric research became the basis for the development of differential diagnostic criteria for the diagnosis and prevention of the development of mental disorders.

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