Two studies of the anti-depressive drug duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), compared its effectiveness and safety to either fluoxetine or placebo in children and adolescents with major depressive disorder (MDD). The results of these first controlled trials of duloxetine in pediatric patients with MDD are published in Journal of Child and Adolescent Psychopharmacology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The articles are available free on the Journal of Child and Adolescent Psychopharmacology website.
Graham Emslie, MD and coauthors evaluated the efficacy and safety of a fixed dose of duloxetine - either 60 mg or 30 mg once a day - versus 20 mg daily of fluoxetine or placebo in children ages 7-11 years and adolescents ages 12-17 years. In the article "A Double-Blind Efficacy and Safety Study of Duloxetine Fixed Doses in Children and Adolescents with Major Depressive Disorder" they compare the treatments based on worsening of suicidal ideation, emergence of suicidal behavior, and adverse effects including abnormal findings on an electrocardiogram and laboratory tests.
Sarah Atkinson, MD and colleagues compared a flexible dosing regimen of duloxetine (60-120 mg daily) to fluoxetine (20-40 mg daily) or placebo and reported measures from a depression rating scale and a suicide severity rating scale, as well as treatment-related adverse events, in the article "A Double-Blind Efficacy and Safety Study of Duloxetine Flexible Dosing in Children and Adolescents with Major Depressive Disorder".
Neither study found a significant difference in response between the two drugs and placebo. The authors suggest that this may be due to the complexity of these novel studies and offer observations that may direct the design of future investigations.
"Drs. Emslie and Atkinson and their colleagues took a fascinating approach towards testing the efficacy of a novel SNRI in the pediatric population," said Harold S. Koplewicz, MD, Editor-in-Chief of Journal of Child and Adolescent Psychopharmacology, and President, Child Mind Institute, New York, NY. "Researchers are of course excited by positive results, but in this case the curious lack of response tells us volumes about how to better design complex studies - studies that may soon give us uncommon insight into our pharmacologic interventions."