The future of child and adolescent clinical psychopharmacology: A systematic review of phase 2, 3, or 4 randomized controlled trials of pharmacologic agents without regulatory approval or for unapproved indications.
Neurosci Biobehav Rev
; 149: 105149, 2023 06.
Article
em En
| MEDLINE
| ID: mdl-37001575
ABSTRACT
We aimed to identify promising novel medications for child and adolescent mental health problems. We systematically searched https//clinicaltrials.gov/ and https//www.clinicaltrialsregister.eu/ (from 01/01/2010-08/23/2022) for phase 2 or 3 randomized controlled trials (RCTs) of medications without regulatory approval in the US, Europe or Asia, including also RCTs of dietary interventions/probiotics. Additionally, we searched phase 4 RCTs of agents targeting unlicensed indications for children/adolescents with mental health disorders. We retrieved 234 ongoing or completed RCTs, including 26 (11%) with positive findings on ≥ 1 primary outcome, 43 (18%) with negative/unavailable results on every primary outcome, and 165 (70%) without publicly available statistical results. The only two compounds with evidence of significant effects that were replicated in ≥ 1 additional RCT without any negative RCTs were dasotraline for attention-deficit/hyperactivity disorder, and carbetocin for hyperphagia in Prader-Willi syndrome. Among other strategies, targeting specific symptom dimensions in samples stratified based on clinical characteristics or established biomarkers may increase chances of success in future development programmes.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Síndrome de Prader-Willi
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Psicofarmacologia
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Transtorno do Deficit de Atenção com Hiperatividade
Tipo de estudo:
Clinical_trials
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Prognostic_studies
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Systematic_reviews
Limite:
Adolescent
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Child
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Humans
Idioma:
En
Revista:
Neurosci Biobehav Rev
Ano de publicação:
2023
Tipo de documento:
Article