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Cited by 29Mental Health Treatment and AccessTreatment of Major DepressionChild and Adolescent Psychosocial and Emotional Development

Generalizability of Clinical Trial Results for Adolescent Major Depressive Disorder

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Blanco, Carlos, Hoertel, Nicolas, Franco, Silvia, Olfson, Mark, He, Jian-Ping, López, Saioa, González-Pinto, Ana, Limosin, Frédéric +1 more·2017·Pediatrics
DOI 10.1542/peds.2016-1701PMC PMC5703774
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Abstract

BACKGROUND: Although there have been a number of clinical trials evaluating treatments for adolescents with major depressive disorder (MDD), the generalizability of those trials to samples of depressed adolescents who present for routine clinical care is unknown. Examining the generalizability of clinical trials of pharmacological and psychotherapy interventions for adolescent depression can help administrators and frontline practitioners determine the relevance of these studies for their patients and may also guide eligibility criteria for future clinical trials in this clinical population. METHODS: Data on nationally representative adolescents were derived from the National Comorbidity Survey: Adolescent Supplement. To assess the generalizability of adolescent clinical trials for MDD, we applied a standard set of eligibility criteria representative of clinical trials to all adolescents in the National Comorbidity Survey: Adolescent Supplement with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of MDD (N = 592). RESULTS: From the overall MDD sample, 61.9% would have been excluded from a typical pharmacological trial, whereas 42.2% would have been excluded from a psychotherapy trial. Among those who sought treatment (n = 412), the corresponding exclusion rates were 72.7% for a pharmacological trial and 52.2% for a psychotherapy trial. The criterion leading to the largest number of exclusions was “significant risk of suicide” in both pharmacological and psychotherapy trials. CONCLUSIONS: Pharmacological and, to a lesser extent, psychotherapy clinical trials likely exclude most adolescents with MDD. Careful consideration should be given to balancing eligibility criteria and internal validity with applicability in routine clinical care while ensuring patient safety.

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Authors
Blanco, C., Hoertel, N., Franco, S., Olfson, M., He, J.-P., López, S., González-Pinto, A., Limosin, F., & Merikangas, K. R.
Affiliations
  • National Institute on Drug Abuse (US)
  • Inserm (FR)
  • Department of Psychiatry, New York State Psychiatric Institute and Columbia University, New York, New York; and
  • New York State Psychiatric Institute (US)
  • Genetic Epidemiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland;
  • Hospital Universitario de Alava (Santiago), Centre for Biomedical Research in Mental Health Network, Vitoria, Spain
  • National Institutes of Health (US)
ORCID
Venue
Pediatrics
Publisher
American Academy of Pediatrics (AAP)
Published
2017-12-01
Volume
140
Issue
6
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.2016-1701
PMC
PMC5703774
OpenAlex
W2766154692
Cited by
29
References
117
Citations by year
2026: 1 · 2025: 5 · 2023: 1 · 2022: 5 · 2021: 5 · 2020: 3 · 2019: 3 · 2018: 5 · 2017: 1
FWCI
4.70
Type
journal article
Language
en
Open access
Locations
  • PEDIATRICS (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health
  • National Institute of Mental Health (R01MH082773, R01MH076051, ZIAMH002808)
Topics
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
Keywords
adolescent major depressive disorder, generalizability of trial results, inclusion and exclusion criteria, exclusion rates, pharmacotherapy, psychotherapy, suicide risk, routine clinical practice
MeSH terms
Adolescent, Clinical Trials as Topic, Major Depressive Disorder, Female, Generalization, Psychological, Health Surveys, Humans, Male, Research Design

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