COMPARISON OF VENLAFAXINE EXTENDED RELEASE W/ PLACEBO

Johns Hopkins University, Baltimore MD

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Linked publications & trials

Abstract

Major depression (MDD) is a significant cause of morbidity & mortality in children & adolescents. Numerous antidepressant agents have been demonstrated to have safety & efficacy in the adult population. However, there is little information on the safety & efficacy of these agents in children & adolescents. To date, only one anti-depressant, fluoxetine, has demonstrated safety & efficacy for the treatment of MDD in children & adolescents. Venlafaxine, a non-specific serotonin re-uptate inhibitor, is an anti-depressant that has received FDA approval for treating depression in the adult poopulation. A formulation of extended-release venlafaxine, venlafaxine ER(V-ER), has now been developed in order to provide once-daily dosing in contrast to the BID or TID dosing of regular, or "immediate release" venlafaxine (V-IR). Preliminary studies for V-ER in adult patients suggest similar efficacy & possibly better tolerability than V-IR. V-ER is of merit in treating depression because of its mixed catecholiminergic & serotonergic activity, its relatively simple side-effect profile at recommended doses, as well as once-a-day dosing. This profile suggests V-ER is of interest in treating the pediatric population because it could have robust antidepressant qualities in addition to helping improve compliance of venlafaxine treatment.