PMID- 36440779
OWN - NLM
STAT- MEDLINE
DCOM- 20221129
LR  - 20221129
IS  - 1997-7298 (Print)
IS  - 1997-7298 (Linking)
VI  - 122
IP  - 11
DP  - 2022
TI  - [Treatment of attention deficit hyperactivity disorder in children: results of a 
      multicenter, randomized, double-blind, placebo-controlled clinical trial].
PG  - 62-68
LID - 10.17116/jnevro202212211162 [doi]
AB  - 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.
FAU - Zavadenko, N N
AU  - Zavadenko NN
AUID- ORCID: 0000-0003-0103-7422
AD  - Pirogov Russian National Research Medical University, Moscow, Russia.
FAU - Makushkin, E V
AU  - Makushkin EV
AUID- ORCID: 0000-0002-1937-5908
AD  - National Medical Research Center for Children's Health, Moscow, Russia.
FAU - Gaynetdinova, D D
AU  - Gaynetdinova DD
AUID- ORCID: 0000-0002-4255-9107
AD  - Kazan State Medical University, Kazan, Russia.
FAU - Kolokolov, O V
AU  - Kolokolov OV
AUID- ORCID: 0000-0001-6672-6873
AD  - Razumovsky Saratov State Medical University, Saratov, Russia.
FAU - Malinina, E V
AU  - Malinina EV
AUID- ORCID: 0000-0002-4791-3881
AD  - Regional Clinical Specialized Psychoneurological Hospital No. 1, Chelyabinsk, 
      Russia.
AD  - South Ural State Medical University, Chelyabinsk, Russia.
FAU - Antipenko, E A
AU  - Antipenko EA
AUID- ORCID: 0000-0002-8972-9150
AD  - Privolzhsky Research Medical University, Nizhny Novgorod, Russia.
FAU - Sagutdinova, E Sh
AU  - Sagutdinova ES
AUID- ORCID: 0000-0002-6752-8382
AD  - European Medical Center UMMC-Health LLC, Yekaterinburg, Russia.
FAU - Khaletskaya, O V
AU  - Khaletskaya OV
AUID- ORCID: 0000-0002-8531-3174
AD  - Privolzhsky Research Medical University, Nizhny Novgorod, Russia.
AD  - NIZHMEDKLINIKA LLC, Nizhny Novgorod, Russia.
FAU - Dmitriev, A V
AU  - Dmitriev AV
AUID- ORCID: 0000-0002-8202-3876
AD  - Pavlov Ryazan State Medical University, Ryazan, Russia.
FAU - Maslova, N N
AU  - Maslova NN
AUID- ORCID: 0000-0003-0183-5643
AD  - Smolensk Regional Clinical Hospital, Smolensk, Russia.
FAU - Mashin, V V
AU  - Mashin VV
AUID- ORCID: 0000-0003-0085-3727
AD  - Children's City Clinical Hospital of Ulyanovsk - Polyclinic No. 1, Ulyanovsk, 
      Russia.
FAU - Panteleeva, M V
AU  - Panteleeva MV
AUID- ORCID: 0000-0002-4099-8202
AD  - Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
LA  - rus
PT  - English Abstract
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
TT  - Terapiya sindroma defitsita vnimaniya s giperaktivnost'yu u detei: rezul'taty 
      mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo 
      klinicheskogo issledovaniya.
PL  - Russia (Federation)
TA  - Zh Nevrol Psikhiatr Im S S Korsakova
JT  - Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
JID - 9712194
RN  - 0 (Tablets)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - Child
MH  - *Attention Deficit Disorder with Hyperactivity/drug therapy/diagnosis
MH  - Double-Blind Method
MH  - Treatment Outcome
MH  - Tablets/therapeutic use
OTO - NOTNLM
OT  - Prospekta
OT  - attention deficit hyperactivity disorder
OT  - children
OT  - pharmacotherapy
OT  - placebo-controlled study
EDAT- 2022/11/29 06:00
MHDA- 2022/11/30 06:00
CRDT- 2022/11/28 07:07
PHST- 2022/11/28 07:07 [entrez]
PHST- 2022/11/29 06:00 [pubmed]
PHST- 2022/11/30 06:00 [medline]
AID - 10.17116/jnevro202212211162 [doi]
PST - ppublish
SO  - Zh Nevrol Psikhiatr Im S S Korsakova. 2022;122(11):62-68. doi: 
      10.17116/jnevro202212211162.