Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007-2018.

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.

Trends in mental health clinical research: Characterizing the ClinicalTrials.gov registry from 2007-2018.

While the epidemiologic burden of mental health disorders in the United States has been well described over the past decade, we know relatively little about trends in how these disorders are being studied through clinical research. We examined all US interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 to identify trends in trial characteristics, comparisons with non-mental health trials, and trial attributes associated with discontinuation and results reporting. International data were excluded to minimize potential confounding. Over this period, mental health and non-mental health trials grew at similar rates, though Industry and US government-funded trials declined and academic medical center/hospital/other (AMC/Hosp/Oth) funded trials grew faster in mental health research. The proportion of trials with safeguards against bias, including blinding and oversight by data monitoring committees (DMCs), decreased. This occurred during growth in the proportion of trials studying behavioral and non-pharmacological interventions, which often cannot be blinded and do not require DMC oversight. There was concurrent decline in pharmaceutical trials. There was significant growth in trials studying Non-DSM (Diagnostic and Statistical Manual-5) conditions (e.g. suicidality and wellness), as well as substance use, anxiety, and neurocognitive disorders. One in 12 trials was discontinued. Trial discontinuation was associated with industry and AMC/Hosp/Oth funders, pharmaceutical interventions, and lack of DMC oversight. Only 29.9% of completed trials reported results to the registry. Decreased results reporting was associated with behavioral interventions, phase 1 trials, and industry and AMC/Hosp/Oth funders. The main implications of these data are that funding is shifting away from traditional government and industry sources, there is increasing interest in non-pharmacological treatments and Non-DSM conditions, and there are changing norms in trial design characteristics regarding safeguards against bias. These trends can guide researchers and funding bodies when considering the trajectory of future mental health research.