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.

GABAergic system Gamalate B6 attention-deficit hyperactivity disorder challenging behavior young adults

Journal

Drugs in context

ISSN: 1745-1981

Titre abrégé: Drugs Context

Pays: England

ID NLM: 101262187

Informations de publication

Date de publication:
2020

Historique:

received: 01 06 2019

revised: 12 12 2019

accepted: 12 12 2019

entrez: 12 3 2020

pubmed: 12 3 2020

medline: 12 3 2020

Statut: epublish

Résumé

We evaluated Gamalate® B6 (GB6) in patients with borderline intellectual functioning (BIF) or mild intellectual development disability (IDD). This was a prospective phase IV observational pilot study in 30 patients who underwent neuropsychological evaluation during treatment with GB6 for 12 weeks. 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. 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.

Sections du résumé

BACKGROUND BACKGROUND

We evaluated Gamalate® B6 (GB6) in patients with borderline intellectual functioning (BIF) or mild intellectual development disability (IDD).

PATIENTS AND METHODS 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 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 CONCLUSIONS

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.

Identifiants

DOI: 10.7573/dic.212601 PMID: 32158489 PMC: PMC7048157

pubmed: 32158489

doi: 10.7573/dic.212601

pii: dic-212601

pmc: PMC7048157

doi:

Types de publication

Journal Article

Langues

eng

Pagination

212601

Informations de copyright

Déclaration de conflit d'intérêts

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

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