Summary of OMH's Report

Key Issues about childhood depression and recent findings

•  Pediatric depression is a real illness and treatment is effective. In the United States, depression is responsible for over 500,000 suicide attempts by children and adolescents each year. Untreated depression carries significant rates of impairment and risk.

•  Currently, fluoxetine (Prozac) is the only antidepressant approved by the FDA for use in pediatric depression (i.e. children and adolescents).  The prescribing of all other antidepressants in children and adolescents for any use is categorized as "off-label" use.

•  To date, only fluoxetine (Prozac) has been shown to be clinically effective with depressed adolescents in two carefully designed research studies.

•  From the FDA's review of antidepressant studies involving 4,400 children and adolescents, they concluded that all the SSRI (including fluoxetine) and other newer antidepressants could increase the risk of suicide-related thoughts and/or self-harming behavior in some children and adolescents (78 of 4,400 patients). The FDA analysis identified the average medication-induced risk to be 4% compared to 2% for a placebo.  This means that statistically, 4 children adolescents out of 100 patients treated might show an increase in suicide thoughts due to the antidepressant medication.  The medication-induced risk is greater when starting or adjusting the dose of these antidepressant medications.

•  In the 24 studies reviewed involving children and adolescents taking SSRI antidepressant medications, there were no deaths.  Also, none of the patients with increased suicidal thoughts or behavior went on to commit suicide.  New research in the treatment of adolescent depression (Treatment for Adolescents with Depression Study - TADS) demonstrates that the combination of therapy (cognitive behavioral therapy) and antidepressant medication (fluoxetine) results in successful treatment (71% of depressed adolescent patients responded positively to the combination treatment compared to 35% of patients on placebo).

•  In spite of the "black box warning", the FDA has not taken a position that SSRI and other new antidepressants are contraindicated in children and adolescents. Therefore, these medications (9 listed above) can continue to be prescribed for children and adolescents if rational prescribing principles are followed.