{
  "abstract": "In this commentary we review the recent approval of escitalopram for generalized anxiety disorder (GAD) in children and adolescents. We critically discuss the FDA approval document and the approval trial. In the approval trial, efficacy was not clinically meaningful, statistical significance uncertain, and there were significantly more adverse events with escitalopram than with placebo. Relative to placebo, children and adolescents exposed to escitalopram were more likely to become suicidal than to experience a clinically relevant improvement in anxiety. Overall, the harm-benefit ratio seems problematic for escitalopram for pediatric GAD.",
  "abstract_shown": true,
  "affiliations": [
    "Center for Inpatient Psychotherapy and Crisis Intervention, University Clinic for Psychiatry, Psychotherapy, and Psychosomatics, Paracelsus Medical University, Salzburg, Austria",
    "Research and Development Department, North East London NHS Foundation Trust, London, UK",
    "Institute of Pharmaceutical Science, King’s College London, London, UK",
    "University of Rennes, Rennes University Hospital, Inserm, Rennes Clinical Investigation Center (CIC1414), Clinical Pharmacology Department, Institute for Research in Health, Environment and Work (Irset)-UMR_S 1085, Rennes, France",
    "Institut Universitaire de France (IUF), Paris, France",
    "Ipswich, UK",
    "Division of Psychiatry, University College London, London, UK"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Martin Plöderl",
      "orcid": "0000-0003-4659-9314"
    },
    {
      "affs": [
        1,
        2
      ],
      "name": "Mark Horowitz",
      "orcid": "0000-0003-1318-2029"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Florian Naudet",
      "orcid": "0000-0003-3760-3801"
    },
    {
      "affs": [
        5
      ],
      "name": "John Warren"
    },
    {
      "affs": [
        6
      ],
      "name": "Joanna Moncrieff",
      "orcid": "0000-0003-1214-6974"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/ah0r246f6zede.bib",
  "cited_by": 0,
  "doi": "10.1177/09246479261456063",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13724250/",
  "id": "ah0r246f6zede",
  "issns": [
    "0924-6479",
    "1878-6847"
  ],
  "landing_url": "https://doi.org/10.1177/09246479261456063",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Opinion Essay"
    ],
    [
      "openalex",
      "2736|Treatment of Major Depression"
    ]
  ],
  "openalex": "W7162678519",
  "pdf_url": null,
  "pmcid": "PMC13724250",
  "pmid": "42206983",
  "published": "2026-05-28",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/ah0r246f6zede.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T12:22:44Z",
      "native_id": "PMC13724250",
      "source": "pmc",
      "url": "https://doi.org/10.1177/09246479261456063"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2736|Treatment of Major Depression",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process",
  "title_text": "Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process",
  "type": "peer-reviewed",
  "updated_at": "2026-11-04T12:22:44Z",
  "url": "https://research.draconitic.com/paper/ah0r246f6zede",
  "venue": "The International Journal of Risk & Safety in Medicine",
  "versions": []
}