Child Psychiatry ClinicalTrials.gov
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 alternative treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%). There were notable differences in funding sources and treatments studied by disorder category. Trials using double blinding declined (26.2% to 18.0%). Funding of US pediatric mental health trials from 2007 to 2018 shifted towards non-traditional sources (i.e., primarily academic medical centers and hospitals). Trials increasingly studied non-pharmacological treatments and Non-DSM-5 conditions. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.
Steps to reproduce
Please see attached protocol. All data downloaded using the relational AACT (Aggregate Analysis of ClinicalTrials.gov) database, which houses data from ClinicalTrials.gov data. We then hand labeled the specific trials that are associated with child psychiatry to add the specific DSM groups associated with each trial. We include a study protocol which describes the diseases we used for grouping trials into specific DSM categories. The data variables and definitions are provided on the ClinicalTrials.gov website (https://clinicaltrials.gov/ct2/about-studies/glossary) and on the AACT website (https://aact.ctti-clinicaltrials.org/learn_more).