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Cortese, Samuele
[Author];
McGinn, Katherine
[Author];
Højlund, Mikkel
[Author];
Apter, Alan
[Author];
Arango, Celso
[Author];
Baeza, Immaculada
[Author];
Banaschewski, Tobias
[Author];
Buitelaar, Jan
[Author];
Castro-Fornieles, Josefina
[Author];
Coghill, David
[Author];
Cohen, David
[Author];
Grünblatt, Edna
[Author];
Hoekstra, Pieter J.
[Author];
James, Anthony
[Author];
Jeppesen, Pia
[Author];
Nagy, Péter
[Author];
Pagsberg, Anne Katrine
[Author];
Parellada, Mara
[Author];
Persico, Antonio M.
[Author];
Purper-Ouakil, Diane
[Author];
Roessner, Veit
[Author];
Santosh, Paramala
[Author];
Simonoff, Emily
[Author];
Stevanovic, Dejan
[Author];
[...]
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
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- Media type: E-Article
- Title: 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
- Contributor: Cortese, Samuele [VerfasserIn]; McGinn, Katherine [VerfasserIn]; Højlund, Mikkel [VerfasserIn]; Apter, Alan [VerfasserIn]; Arango, Celso [VerfasserIn]; Baeza, Immaculada [VerfasserIn]; Banaschewski, Tobias [VerfasserIn]; Buitelaar, Jan [VerfasserIn]; Castro-Fornieles, Josefina [VerfasserIn]; Coghill, David [VerfasserIn]; Cohen, David [VerfasserIn]; Grünblatt, Edna [VerfasserIn]; Hoekstra, Pieter J. [VerfasserIn]; James, Anthony [VerfasserIn]; Jeppesen, Pia [VerfasserIn]; Nagy, Péter [VerfasserIn]; Pagsberg, Anne Katrine [VerfasserIn]; Parellada, Mara [VerfasserIn]; Persico, Antonio M. [VerfasserIn]; Purper-Ouakil, Diane [VerfasserIn]; Roessner, Veit [VerfasserIn]; Santosh, Paramala [VerfasserIn]; Simonoff, Emily [VerfasserIn]; Stevanovic, Dejan [VerfasserIn]; Stringaris, Argyris [VerfasserIn]; Vitiello, Benedetto [VerfasserIn]; Walitza, Susanne [VerfasserIn]; Weizman, Abraham [VerfasserIn]; Wohlfarth, Tamar [VerfasserIn]; Wong, Ian C. K. [VerfasserIn]; Zalsman, Gil [VerfasserIn]; Zuddas, Alessandro [VerfasserIn]; Moreno, Carmen [VerfasserIn]; Solmi, Marco [VerfasserIn]; Correll, Christoph U. [VerfasserIn]
- imprint: June 2023
- Published in: Neuroscience & biobehavioral reviews ; 149(2023) vom: Juni, Artikel-ID 105149, Seite 1-30
- Language: English
- DOI: 10.1016/j.neubiorev.2023.105149
- ISSN: 1873-7528
- Identifier:
- Keywords: Adolescents ; Children ; Dietary interventions ; Medications ; Probiotics ; Psychopharmacology
- Origination:
-
Footnote:
Online verfügbar: 29. März 2023, Artikelversion: 14. April 2023
- Description: 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.
- Access State: Open Access