@article{ref1,
title="Safety of subchronic treatment with fluoxetine for major depressive disorder in children and adolescents",
journal="Journal of child and adolescent psychopharmacology",
year="2004",
author="Nilsson, Mary and Joliat, Melissa J. and Miner, Cherri M. and Brown, Eileen B. and Heiligenstein, John H.",
volume="14",
number="3",
pages="412-417",
abstract="OBJECTIVE: The aim of this study was to assess the safety of subchronic fluoxetine treatment for major depressive disorder (MDD) in children and adolescents. METHODS: Patients received up to 19 weeks of treatment with fluoxetine, 10 mg-60 mg daily. Safety was evaluated through the reporting of concomitant medications, vital signs, routine laboratory testing, electrocardiograms (ECGs), and adverse event data. RESULTS: Ninety-six patients, aged 9-17 years, completed 19 weeks of treatment with fluoxetine (n = 49) or placebo (n = 47). There were statistically significant differences between the fluoxetine and placebo groups in mean change from baseline for alkaline phosphatase and total cholesterol levels (p < 0.001, and p < 0.014, respectively), but there were no statistically significant differences between the incidence of abnormal laboratory values for these 2 analytes. Fluoxetine-treated patients gained statistically significantly less height (fluoxetine: 1.0 cm +/- 2.4; placebo: 2.1 cm +/- 2.6; p = 0.004) and weight (fluoxetine: 1.2 kg +/- 2.7; placebo: 2.3 kg +/- 2.6; p = 0.008) than placebo-treated patients during the 19 weeks of treatment. There was no difference in the rate of reported suicide-related events between fluoxetine and placebo. CONCLUSION: Fluoxetine was found to be safe and well tolerated in this study of children and adolescents with MDD. Clarification and determination of the clinical significance of the growth-rate reduction seen during fluoxetine treatment requires further investigation. During treatment with fluoxetine, the growth of child and adolescent patients should be monitored.<p /><p>Language: en</p>",
language="en",
issn="1044-5463",
doi="10.1089/cap.2004.14.412",
url="http://dx.doi.org/10.1089/cap.2004.14.412"
}