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Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD

BACKGROUND: We evaluated Gamalate® B6 (GB6) in patients with borderline intellectual functioning (BIF) or mild intellectual development disability (IDD). PATIENTS AND METHODS: This was a prospective phase IV observational pilot study in 30 patients who underwent neuropsychological evaluation during...

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Autores principales: Novell, Ramón, Esteba-Castillo, Susanna, Rodriguez, Emili
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioExcel Publishing Ltd 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048157/
https://www.ncbi.nlm.nih.gov/pubmed/32158489
http://dx.doi.org/10.7573/dic.212601
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author Novell, Ramón
Esteba-Castillo, Susanna
Rodriguez, Emili
author_facet Novell, Ramón
Esteba-Castillo, Susanna
Rodriguez, Emili
author_sort Novell, Ramón
collection PubMed
description BACKGROUND: We evaluated Gamalate® B6 (GB6) in patients with borderline intellectual functioning (BIF) or mild intellectual development disability (IDD). PATIENTS AND METHODS: This was a prospective phase IV observational pilot study in 30 patients who underwent neuropsychological evaluation during treatment with GB6 for 12 weeks. RESULTS: In comparison with baseline, the responses were positive, with a significant improvement in hyperactivity (51.7%), irritability (35.5%), and logorrhea (50%), and no sedative effect. The Clinical Global Impressions – Severity (CGI-S) score was much improved or very much improved in 73% of cases. Reaction time was better with fewer errors, thus indicating an improvement in attentional processes. A statistically significant result was obtained for the number of movements used to solve the problem and for the total number of correctly solved problems. CONCLUSION: In this pilot study, GB6 was effective and well tolerated in cases of ADHD and challenging behavior in young adults with borderline-to-mild BIF/IDD. However, given the small number of patients involved and the uncontrolled nature of the study, these results should be viewed cautiously.
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spelling pubmed-70481572020-03-10 Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD Novell, Ramón Esteba-Castillo, Susanna Rodriguez, Emili Drugs Context Original Research BACKGROUND: We evaluated Gamalate® B6 (GB6) in patients with borderline intellectual functioning (BIF) or mild intellectual development disability (IDD). PATIENTS AND METHODS: This was a prospective phase IV observational pilot study in 30 patients who underwent neuropsychological evaluation during treatment with GB6 for 12 weeks. RESULTS: In comparison with baseline, the responses were positive, with a significant improvement in hyperactivity (51.7%), irritability (35.5%), and logorrhea (50%), and no sedative effect. The Clinical Global Impressions – Severity (CGI-S) score was much improved or very much improved in 73% of cases. Reaction time was better with fewer errors, thus indicating an improvement in attentional processes. A statistically significant result was obtained for the number of movements used to solve the problem and for the total number of correctly solved problems. CONCLUSION: In this pilot study, GB6 was effective and well tolerated in cases of ADHD and challenging behavior in young adults with borderline-to-mild BIF/IDD. However, given the small number of patients involved and the uncontrolled nature of the study, these results should be viewed cautiously. BioExcel Publishing Ltd 2020-01-23 /pmc/articles/PMC7048157/ /pubmed/32158489 http://dx.doi.org/10.7573/dic.212601 Text en Copyright © 2020 Novell R, Esteba-Castillo S, Rodriguez E. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.
spellingShingle Original Research
Novell, Ramón
Esteba-Castillo, Susanna
Rodriguez, Emili
Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title_full Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title_fullStr Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title_full_unstemmed Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title_short Efficacy and safety of a GABAergic drug (Gamalate® B6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and ADHD
title_sort efficacy and safety of a gabaergic drug (gamalate® b6): effects on behavior and cognition in young adults with borderline-to-mild intellectual developmental disabilities and adhd
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048157/
https://www.ncbi.nlm.nih.gov/pubmed/32158489
http://dx.doi.org/10.7573/dic.212601
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