Carlos Blanco1, Nicolas Hoertel2,3,4, Silvia Franco5, Mark Olfson5, Jian-Ping He6, Saioa López7, Ana González-Pinto7, Frédéric Limosin8,3,4, Kathleen R Merikangas6. 1. Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, Bethesda, Maryland. 2. Paris Descartes University, Pôles de recherche et d'enseignement supérieur Sorbonne Paris Cité, Paris, France; nico.hoertel@yahoo.fr. 3. Department of Psychiatry, Assistance Publique-Hôpitaux de Paris, Hôpital Corentin-Celton, Issy-les-Moulineaux, France. 4. Institut national de la santé et de la recherche médicale unité mixte de recherche 894, Psychiatry and Neurosciences Center, Paris, France. 5. Department of Psychiatry, New York State Psychiatric Institute and Columbia University, New York, New York; and. 6. Genetic Epidemiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland. 7. Hospital Universitario de Alava (Santiago), Centre for Biomedical Research in Mental Health Network, Vitoria, Spain. 8. Paris Descartes University, Pôles de recherche et d'enseignement supérieur Sorbonne Paris Cité, Paris, France.
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.
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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