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P01-219 - Clinical Efficacy of Tenoten for Children in Treatment of Attention Deficit and Hyperactivity Disorder

Published online by Cambridge University Press:  17 April 2020

I. Kheyfets ,
L. Chutko ,
S. Surushkina ,
J. Dugina ,
M. Kachanova ,
S. Sergeeva  and
O. Epstein
I. Kheyfets
Affiliation:
OOO ‘NPF lrsquo;Materia Medica Holding’, Moscow
L. Chutko
Affiliation:
Human Brain Research Institute RAS, Saint Petersburg, Russia
S. Surushkina
Affiliation:
Human Brain Research Institute RAS, Saint Petersburg, Russia
J. Dugina
Affiliation:
OOO ‘NPF lrsquo;Materia Medica Holding’, Moscow
M. Kachanova
Affiliation:
OOO ‘NPF lrsquo;Materia Medica Holding’, Moscow
S. Sergeeva
Affiliation:
OOO ‘NPF lrsquo;Materia Medica Holding’, Moscow
O. Epstein
Affiliation:
OOO ‘NPF lrsquo;Materia Medica Holding’, Moscow

Abstract

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Objectives

To assess efficacy and safety of tenoten for children (TC, ultra-low doses of antibodies to S100 protein) in ADHD patients.

Methods

In a double-blind placebo-controlled study 50 children (6-12 years) met DSM-IV criteria, mild/moderate CGI-ADHD-Severity and ADHDRS-IV-Parent:Inv > 22 points were enrolled. Patients were randomized to receive either TC (2 tablets BID, n=25) or placebo (n=25) for 12 weeks. ADHD symptoms were assessed by ADHDRS-IV-Parent:Inv, CPRS-R:S and CGI-ADHD-Severity.

Results

According to both parents and investigators assessment TC decreased ADHD symptoms: ADHDRS-IV total score reduced by 13.5 points, hyperactivity by 6.7 points, inattention by 6.8 points (5.4, 2.3 and 3.2 in placebo); CPRS-R:S total score reduced by 12.8 points, hyperactivity by 3.6 points, inattention by 6.1 points (4.8, 1.8 and 1.7 in placebo). ADHD severity reduced in 9 patients received TC and 3 patients received placebo. No adverse effects were reported in both groups.

Conclusions

The study demonstrated good clinical efficacy and safety of TC in children with ADHD.

 Total score (M±m)Hyperactivity (M±m)Inattention (M±m)
 Baseline12 weekBaseline12 weekBaseline12 week
ADHDRS-IV
TC34.2±1.3920.7±1.84**15.8±1.009.1±1.06*18.4±0.6311.6±0.96**
Placebo33.6±1.2628.2±1.8215.0±0.8712.7±0.9918.7±0.5115.5±0.96
CPRS-R:S
TC47.6±2.4634.8±2.61**9.7±0.796.1±0.58***23.5±1.0717.4±1.15***
Placebo51.9±2.2547.1±2.5911.3±0.759.8±0.7924.9±0.9323.2±0.99

*,*,*** - p< 0.05; p< 0.01; p< 0.001 vs placebo

Type
Child and adolescent psychiatry
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E425
Copyright
Copyright © European Psychiatric Association 2010
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