[Treatment of attention deficit hyperactivity disorder in children: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial].

Autor:	Zavadenko NN; Pirogov Russian National Research Medical University, Moscow, Russia., Makushkin EV; National Medical Research Center for Children's Health, Moscow, Russia., Gaynetdinova DD; Kazan State Medical University, Kazan, Russia., Kolokolov OV; Razumovsky Saratov State Medical University, Saratov, Russia., Malinina EV; Regional Clinical Specialized Psychoneurological Hospital No. 1, Chelyabinsk, Russia.; South Ural State Medical University, Chelyabinsk, Russia., Antipenko EA; Privolzhsky Research Medical University, Nizhny Novgorod, Russia., Sagutdinova ES; European Medical Center UMMC-Health LLC, Yekaterinburg, Russia., Khaletskaya OV; Privolzhsky Research Medical University, Nizhny Novgorod, Russia.; NIZHMEDKLINIKA LLC, Nizhny Novgorod, Russia., Dmitriev AV; Pavlov Ryazan State Medical University, Ryazan, Russia., Maslova NN; Smolensk Regional Clinical Hospital, Smolensk, Russia., Mashin VV; Children's City Clinical Hospital of Ulyanovsk - Polyclinic No. 1, Ulyanovsk, Russia., Panteleeva MV; Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2022; Vol. 122 (11), pp. 62-68.
DOI:	10.17116/jnevro202212211162
Abstrakt:	Objective: Evaluation of the efficacy and safety of the new drug Prospekta in the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 7-12 years. Material and Methods: A multicenter (35 clinical centres) double-blind, placebo-controlled, randomized, parallel-group clinical trial enrolled 363 patients. The mean age was 9.3±1.7 years. Children of both sexes aged between 7 and 12 years with a diagnosis of ADHD confirmed by DSM-V diagnostic criteria were included in the study. Patients with a total score of 22 or more on the Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) were included in the study. After randomisation, patients in group 1 received Prospekta, 1 tablet twice daily; patients in group 2 received placebo according to the study drug regimen. The primary efficacy criterion was the proportion of patients with a 25% or greater reduction in the overall ADHD-RS-V scale score after 8 weeks of treatment. As additional criteria for efficacy assessment were assessed: change of ADHD-RS-V total score from baseline after 8 weeks of treatment; Clinical Global Impression Efficacy Index (CGI-EI) score after 8 weeks of treatment; side effects. Results: The proportion of patients with a 25% or more reduction in the ADHD-RS-V scale score after 8 weeks of treatment was 55.9% in the Prospekta group, and 43.3% in the placebo group ( p =0.0199). There was a reduction of ADHD symptoms in the Prospekta group as a mean ADHD-RS-V score decreased by 10.2±7.7 (in the placebo group by 8.1±7.9); the difference between the mean ADHD-RS-V score reduction during Prospekta and placebo treatment was 2.09±7.81 ( p =0.0096). Mean CGI-EI scores calculated on the basis of physician scores were different in the Prospekta group compared to the placebo group at 6.9±3.2 versus 8.0±3.1 ( p =0.0012), indicating greater clinical efficacy of the study drug. The frequency of adverse events (AEs) did not differ significantly between the groups. There were a total of 66 AEs in 46 patients, including 31 AEs in 23 (13.2%) Prospekta group participants and 35 AEs in 23 (12.2%) placebo group participants ( p =0.87). No cases of serious AEs were reported during the study. Prospekta is compatible with drugs used in pediatric practice. Prospekta did not cause an exciting effect and did not adversely affect the sleep of patients. Conclusion: The drug Prospekta is an effective and safe treatment for ADHD in patients 7-12 years old.
Databáze:	MEDLINE
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