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

Cortese, Samuele; McGinn, Katherine; Højlund, Mikkel; Apter, Alan; Arango, Celso; Baeza, Immaculada; Banaschewski, Tobias; Buitelaar, Jan; Castro-Fornieles, Josefina; Coghill, David; Cohen, David; Grünblatt, Edna; Hoekstra, Pieter J; James, Anthony; Jeppesen, Pia; Nagy, Péter; Pagsberg, Anne Katrine; Parellada, Mara; Persico, Antonio M; Purper-Ouakil, Diane

doi:10.5167/uzh-232755

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Cortese, S., McGinn, K., Højlund, M., Apter, A., Arango, C., Baeza, I., Banaschewski, T., Buitelaar, J., Castro-Fornieles, J., Coghill, D., Cohen, D., Grünblatt, E., Hoekstra, P. J., James, A., Jeppesen, P., Nagy, P., Pagsberg, A. K., Parellada, M., Persico, A. M., … Correll, C. U. (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. Neuroscience and Biobehavioral Reviews, 149, 105149. https://doi.org/10.1016/j.neubiorev.2023.105149

Abstract

The pace of development and implementation of novel medications in child and adolescent psychiatry has remained slow. We systematically searched https://clinicaltrials.gov/ and https://www.clinicaltrialsregister.eu/ (from 01/01/2010 to 08/23/2022) for phase 2 or 3 randomized controlled trials (RCTs) of medications without regulatory approval in the US, Europe or Asia. We also included RCTs of dietary interventions/probiotics. Additionally, we searched phase 4 RCTs of agents targeting unlicensed indications for children/adolescents wit