Abstract
Whereas time trends in the epidemiologic burden of US pediatric mental health disorders are well described, little is known about trends in how these disorders are studied through clinical research. We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials. We identified all US pediatric interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 (n = 1,019) and manually characterized disorders and treatments studied. We assessed trial growth and design characteristics by funding source, treatments, and disorders. US pediatric mental health trials grew over the past decade (compound annual growth rate [CAGR] 4.1%). The number of studies funded by industry and US government remained unchanged, whereas studies funded by other sources (e.g., academic medical centers) grew (CAGR 11.3%). Neurodevelopmental disorders comprised the largest proportion of disorders studied, and Non-DSM-5 (Diagnostic and Statistical Manual-5) conditions was the only disorder category to grow (14.5% to 24.6%; first half to second half of decade). There was significant growth of trials studying non-psycho/pharmacotherapy treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%), though these trends differed by funding source. There were also notable differences in funding sources and treatments studied within each disorder category. Trials using double blinding declined (26.2% to 18.0%). Limitations include that ClinicalTrials.gov is not an exhaustive list of US clinical trials, and trends identified may in part reflect changes in trial registration rather than changes in clinical research. Nevertheless, ClinicalTrials.gov is among the largest databases available for evaluating trends and patterns in pediatric mental health research that might otherwise remain unassessable. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.
Highlights
Time trend data are fundamental to epidemiological research [1], and they are widely studied in psychiatry and psychology [2, 3]
We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials
US pediatric mental health trials grew over the past decade
Summary
Time trend data are fundamental to epidemiological research [1], and they are widely studied in psychiatry and psychology [2, 3]. Increases in the prevalence of pediatric mental health conditions are significant and extend to multiple psychiatric disorders [4]. In the 1960s, one in 2,500 children was diagnosed with autism [5], yet by 2014, this number was as high as one in every 59 children in the United States [6]. Current estimates of the prevalence of attention deficit hyperactivity disorder (ADHD) are between 4–12% in school aged children, representing a 24% increase since 2001 [7]. The number of US children diagnosed with either depression or anxiety has increased from 5.4% in 2003 to 8.4% in 2012 [8]. The extent to which these trends reflect changes in assessment tools and diagnostic sensitivity is subject to some debate; in contrast to the epidemiology, little is known about accompanying time trends in pediatric mental health clinical research
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