Review of the efficacy and safety of antidepressants in youth depression.
BACKGROUND
Depression in children and adolescents is a cause of substantial morbidity and mortality in this population. It is a common disorder that affects 2% of children and up to 6% of adolescents. Although antidepressants are used frequently for the treatment of this disorder, there has been recent controversy about the efficacy and safety of these medications in this population. This review examined the available evidence from clinical trials of antidepressants in adolescents and children with depression.


METHODS
Clinical trial data reviewed were obtained from published reports, including peer review journals and meeting abstracts, as well as unpublished data in the public domain. Clinical trials in this review included large RCTs of antidepressants in youth under the age of 19 with depression. Studies were identified in 2 stages: 1) all RCTs included in the 2004 FDA safety report were reviewed; and 2) to ensure that no additional studies not reported to the FDA were missed, MEDLINE and PSYCH Info were searched from inception until December 2004. A total of 8 published studies and 9 unpublished studies were identified and reviewed.


RESULTS
Efficacy and safety results from each study are reviewed in detail. There are significant differences in remission and response rates between different antidepressants but also between placebo groups across studies. Adverse events are common in clinical trials involving children and adolescents with depression. Due to lack of access to full data sets, effect sizes could not be calculated.


CONCLUSIONS
With the variability in trial methodology and the variation in the drug/placebo response rates within a single trial, clinicians need to be judicious in their interpretation of research data on pediatric antidepressant trials. Significant methodological issues may also have affected the efficacy and safety results from these clinical trials.
Cheung
Amy H
AH
Department of Psychiatry, University of Toronto, Ontario, Canada. Amy_cheung@camh.net
Emslie
Graham J
GJ
Mayes
Taryn L
TL
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000139:chemically induced; D002648:Child; D003866:Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D012449:Safety; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013405:Suicide; D016896:Treatment Outcome
D000928:Antidepressive Agents; D018687:Antidepressive Agents, Second-Generation; D017367:Selective Serotonin Reuptake Inhibitors