Few clinical drug trials exist for pediatric neuropsychiatric conditions

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1. Only 10% of clinical neuropsychiatric drug trials from 2006 to 2011 were pediatric trials. 

2. Drug trials for depression (6%) and schizophrenia (6%) made up the smallest proportion of pediatric neuropsychiatric trials. 

Evidence Rating Level: 1 (Excellent)

Study Rundown: There has been an increasing prevalence of neuropsychiatric disease among the pediatric population, which now reaches nearly 20%. However, there remain few clinical drug trials for pediatric depression, bipolar disorder, schizophrenia, migraine, and epilepsy. Children are often treated with unlicensed medications with known efficacy in adults, but without pediatric-specific guidelines. Only 10% of clinical drug trials between 2006 and 2011 for these conditions are pediatric trials. Furthermore, schizophrenia and depression, which represent the largest neuropsychiatric disease burden in youth, had the fewest drug trials devoted to them. One possible limitation is that the ClinicalTrials.gov registry, used for data collection, may not have included all relevant trials. Also, missing data and lack of verification of information provided in the registry could have contributed to errors. Nonetheless, this study points to the need for more clinical drug trials to guide safe and effective treatment for neuropsychiatric conditions in children.

Click to read the study published today in Pediatrics

Relevant Reading: Pediatric Psychopharmacology

In-Depth [retrospective review study]: A total of 1046 clinical drug trials on pediatric and adult drug treatments for neuropsychiatric conditions were included. Only 10% (108/1046) of all neuropsychiatric drug trials were pediatric. Furthermore, the fewest drug trials existed for pediatric depression and schizophrenia (6% each, 17/308 and 16/290, respectively). Antiepileptics were most commonly studied drugs in children (51%, 25/49). Most (90%, 273/303) of the drugs studied were not FDA-approved for pediatric use. In addition, only 19% (47/303; 95% CI: 15-23%) of all neuropsychiatric drugs were being studied for pediatric use, in comparison with the 95% (288/303; 95% CI: 93-975) for adult use. The majority (76%, 74/97) of pediatric trials sought to expand drug use labeling from adult to pediatric age groups, while 32% (95% CI: 29-35%) of adult trials were investigating new drugs. Moreover, 26% (25/97; 95% CI: 17-35%) of pediatric trials evaluated a drug for a new indication, as compared to 42% (95% CI 38-46%) of adult trials.

By Cordelia Y. Ross and Devika Bhushan

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