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In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.
In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients. The results were published in the Journal of the American Medical Association (JAMA).
The study included the pooled results of all (N=27) available randomized, placebo-controlled trials of various second-generation antidepressants (selective serotonin reuptake inhibitors [SSRIs], nefazadone, venlafaxine and mirtazapine) used for a variety of indications including pediatric major depressive disorder (MDD) (n=15), obsessive-compulsive disorder (OCD) (n=6), and non-OCD anxiety disorders (n=6).
Antidepressants were associated with a 37.1% response rate for non-OCD anxiety disorders (95% CI, 22.5%–51.7%), a 19.8% response rate for OCD (95% CI, 13.0%–26.6%), and an 11.0% response rate for MDD (95% CI, 7.1%–14.9%). Among children aged <12 years with MDD, only fluoxetine was demonstrated to be beneficial compared with placebo.
"Consistent with the analyses of the FDA, we found evidence of an overall small but increased risk of treatment-emergent suicidal ideation/suicide attempt," the authors stated.
Based upon these results, the investigators stated: "Depending on treatment indication, the number needed to treat ranges from 3 to 10, while the number needed to harm via emergence of suicidal ideation/suicide attempt ranges from 112 to 200, indicating a favorable overall risk-to-benefit profile for antidepressants in the treatment of pediatric MDD, OCD, and non-OCD anxiety disorders."
"We believe that the strength of evidence presented here supports the cautious and well monitored use of antidepressant medications as 1 of the first-line treatment options, with the recognition that efficacy appears greatest for non-OCD anxiety disorders, intermediate for OCD, and more modest for MDD," the authors stated.
Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA. 2007;297:1683–1696.