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

Article Details

Authors
Ramón Novell MD, Susanna Esteba-Castillo PhD, Emili Rodriguez PhD

Article Type
Original Research

DOI
10.7573/dic.212601

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Abstract

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.

Keywords: attention-deficit hyperactivity disorder, challenging behavior, young adults, GABAergic system, Gamalate B6.

Citation: Novell R, Esteba-Castillo S, Rodriguez E. 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. Drugs in Context 2020; 9: 212601. DOI: 10.7573/dic.212601

Contributions: All authors contributed extensively to the work presented in this paper. All authors have contributed significantly to the conception, design, data collection, and execution of the study. All authors participated in drafting and/or reviewing the manuscript and have approved its submission. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at https://www.drugsincontext.com/wp-content/uploads/2019/12/dic.212601-COI.pdf

Acknowledgments: Writing and editorial assistance was provided by Content Ed Net (Madrid, Spain).

Funding declaration: Funding for editorial assistance was provided by Ferrer Internacional SA (Barcelona, Spain). No external funding was received for the research work.

Copyright: Copyright © 2020 Novell R, Esteba-Castillo S, Rodriguez E. https://doi.org/10.7573/dic.212601. 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.

Correct attribution: 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.

Article URL: https://www.drugsincontext.com/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/

Correspondence: Ramon Novell, Specialized Service in Mental Health and Intellectual Disability (SEMSDI), Parc Hospitalàri Martí i Julià, Instituto de Asistencia Sanitaria, Girona, Spain. ramon.novell@ias.cat

Provenance: invited; externally peer reviewed.

Submitted: 1 June 2019; Peer review comments to author: 18 July 2019; Revised manuscript received: 12 December 2019; Accepted: 12 December 2019; Publication date: 23 January 2020.

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