Objective: Pediatric trials in depression have led to major concerns about potential suicide inducing properties of antidepressants and doubts about their efficacy. Several trials of anti-manic agents in children were recently conducted and regulatory reviews of the data have become available. Methods: We acquired pediatric and adult anti-mania agent Medical and Statistical Reports from the U.S. FDA. We used these to evaluate efficacy, mortality, severe adverse events and suicidality. Results: The six pediatric studies enrolled 1,228 patients (828 drug/460 placebo). The seven adult drug approval programs enrolled 4,228 patients (2,356 drug/1,932 placebo). Mean mania rating scale baseline (pediatric=30.3/adult=30.3) scores were identical, and drug-placebo difference scores (pediatric=5.8/ adult=5.2) were not significantly different. There were no reported deaths during the pediatric trials. During the 23 adult trials there were 8 deaths (3 in drug group/5 in placebo group), a mortality rate of 3,290/100,000 patient exposure years. The proportion of patients that reported severe adverse events was slightly lower for the pediatric (4.2%) as compared to adult (4.7%) trials. A higher proportion of children (5/460, 1.1%) than adult (7/2,012, 0.3%) patients assigned to placebo reported suicidality, χ2(df=1)=4.2, p=0.04. We did not find evidence of increased suicidality for children assigned to drug (7/828, 0.8%) as compared to the children assigned to placebo (5/460, 1.1%).
|Original language||English (US)|
|Number of pages||6|
|Journal||Israel Journal of Psychiatry and Related Sciences|
|State||Published - Aug 6 2012|
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health