OBJECTIVES : Approximately 2.1 percent of U.S. children aged 3 to 17 years had a diagnosable major depression. Children with depressive disorder are at higher risk for substance abuse, social dysfunction, and suicide. However, there is limited FDA approved medications for depression treatment in pediatric population. Despite widespread use of off-label medications, little research is available for children. The study aimed to investigate the trend and patterns of off-label prescribing by physicians for the treatment of depression in children and adolescents.

METHODS : A population-based study was conducted by analyzing the National Ambulatory Medical Care Survey (NAMCS) 2010 to 2014. Patients aged 3 to 17 years with a diagnosis of depression were included. A weighted logistic regression was performed to examine the off-label drug use patterns across various patient and physician characteristics. Data trends were graphically plotted and further analyzed using Mann-Kendall (M-K) trend test. All analyses utilized SAS PROC SURVEY applications and incorporated sample weights to adjust for the complex sampling design.

RESULTS : Among 23.3 million outpatient visits with depression, 1.28 million (5.5%) of them were children. Approximately 82.4% received at least one off-labeled medication. SSRI was the most frequent therapeutic class for off-label use, followed by Phenylpiperazine and Atypical Antipsychotic, etc. Sertraline was the highest individual off-label prescription, followed by Trazodone and Citalopram, etc. The M-K test demonstrated no significant monotonic trend relationship. (Kendall’s tao= -0.2; P=0.62) The weighted logistic regression showed that gender, pay-type, region, metropolitan, and major reason of visit were significantly associated with off-label drug use.

CONCLUSIONS : Although off-label drug use is legal and common, health care providers should be aware that its safety and efficacy in pediatric patients have not been fully established. It is important for FDA and researchers to remain committed to keeping pediatric drug development a high priority and to ensuring those drugs appropriately labeled for children.