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Article Dans Une Revue Neuroscience and Biobehavioral Reviews Année : 2023

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

1 University of Southampton
2 NYU Langone Health [New York]
3 UON - University of Nottingham, UK
4 The Feinstein Institute for Medical Research
5 SDU - University of Southern Denmark
6 RUNI - Reichman University [Herzliya]
7 UCM - Universidad Complutense de Madrid = Complutense University of Madrid [Madrid]
8 University of Barcelona
9 Universität Heidelberg [Heidelberg] = Heidelberg University
10 Radboud University Medical Center [Nijmegen]
11 University of Melbourne
12 CHU Pitié-Salpêtrière [AP-HP]
13 ISIR - Institut des Systèmes Intelligents et de Robotique
14 UZH - Universität Zürich [Zürich] = University of Zurich
15 University of Groningen [Groningen]
16 University of Oxford
17 UCPH - University of Copenhagen = Københavns Universitet
18 UNIMORE - Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia
19 CESP - Centre de recherche en épidémiologie et santé des populations
20 CHU Montpellier
21 TU Dresden - Technische Universität Dresden = Dresden University of Technology
22 King‘s College London
23 GU - Göteborgs Universitet = University of Gothenburg
24 UCL - University College of London [London]
25 NKUA - National and Kapodistrian University of Athens
26 UNITO - Università degli studi di Torino = University of Turin
27 UvA - University of Amsterdam [Amsterdam] = Universiteit van Amsterdam
28 HKU - The University of Hong Kong
29 TAU - Tel Aviv University
30 Columbia University [New York]
31 University of Cagliari
32 University of Ottawa [Ottawa]
33 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
34 ZHH - Zucker Hillside Hospital [Glen Oaks, NY, USA]
A. Weizman

Résumé

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.
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Dates et versions

hal-04106311 , version 1 (02-06-2023)

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Samuele Cortese, Katherine Mcginn, Mikkel Højlund, Alan S. Apter, Celso Arango, et al.. 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. Neuroscience and Biobehavioral Reviews, 2023, 149, ⟨10.1016/j.neubiorev.2023.105149⟩. ⟨hal-04106311⟩
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