Research Topic

Real-World Evidence of Pediatric Exposure to Psychopharmacologic Medications

About this Research Topic

The prescription of psychotropic medication to very young children and adolescents in clinical practice settings has expanded faster than evidence of the safety regarding child social, emotional, and developmental outcomes. The prescribed psychotropic medication classes, such as stimulants, antidepressants, ...

The prescription of psychotropic medication to very young children and adolescents in clinical practice settings has expanded faster than evidence of the safety regarding child social, emotional, and developmental outcomes. The prescribed psychotropic medication classes, such as stimulants, antidepressants, antipsychotics, mood stabilizers, and sedative/hypnotics, are being prescribed in combination, sometimes with three or four different therapeutic classes. This practice is ‘off label’ without an approved indication and therefore lacks rigorous scientific evidence to support the safe and effective use in children and adolescents. There is a need for better data and real-world evidence of the outcomes of early life exposure to psychotropic medications.

The goals of this Research Topic are to provide the state of the evidence for the safety of psychotropic medication use in children and adolescents. This information will help to advance paradigms for the generation of real-world evidence that bridge pharmacogenomic, clinical pharmacology, and pharmacoepidemiologic research with clinical interventions that promote safe and effective use of psychotropic medications in children.

We welcome Original Research addressing the above goal, including clinical data and observational studies on population health outcomes. Manuscripts that use clinical data to understand mechanisms for potential harms, use pharmacoepidemiologic data to examine population outcomes, and address the ethical issues in generating better evidence of the harms and benefits of psychotropic medication use in children and adolescents are encouraged.

We specifically encourage submissions addressing the following topics in therapeutic areas relevant to this Research Topic (i.e., stimulants and other medications for attention-deficit/hyperactivity disorder, antidepressants, antipsychotics, mood stabilizers, and sedative/hypnotic drugs):

• Effects of early life or prenatal exposure to psychopharmacologic medications on developmental outcomes in the first 5-years of life;
• Post-marketing studies (e.g., registries, electronic health records, administrative data) of the therapeutic outcomes and potential harms of concomitant use of two or more psychotropic medications;
• Pharmacogenomic research on biological and physiological mechanisms underlying adverse events;
• Global trends in indicated use and off-label use of psychotropic medication;
• Comparative effectiveness and safety of monotherapy and concomitant treatments;
• Ethical issues on generating better post-marketing data and strategies for better evidence generation.


Keywords: neurodevelopmental, psychotropic medication, pharmacoepidemiology, effectiveness outcomes, pharmacogenomic


Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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Submission Deadlines

16 December 2020 Manuscript
16 January 2021 Manuscript Extension

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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Topic Editors

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Submission Deadlines

16 December 2020 Manuscript
16 January 2021 Manuscript Extension

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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