Abstract
The diagnosis of major depressive disorder (MDD) in U.S. youth is increasing as is the rate of antidepressant medication (ADM) treatment for the disorder. Fluoxetine and escitalopram are FDA approved for the short term and maintenance treatment of MDD in youth. Placebo-controlled short-term ADM trials represent the basis for Food and Drug Administration (FDA) approval. Meta-analyses in 2007 and 2016 revealed that short-term ADM treatment of youth diagnosed with MDD resulted in no meaningful benefit for children and only marginal benefit for adolescents. Placebo substitution trials of ADM short-term responders represent the basis for FDA approval of ADM maintenance treatment. These ADM placebo substitution maintenance trials for youth with MDD are characterized by high dropout rates, a rapid withdrawal that often can follow the switch to placebo, and relapse rates that are not dissimilar from those in the natural course of the disorder. Without the evidence from problematic ADM placebo substitution trials, there is no acceptable support for the inclusion of ADM in maintenance treatment for MDD in youth.
Highlights
Placebo substitution trials of antidepressant medication (ADM) short-term responders represent the basis for Food and Drug Administration (FDA) approval of ADM maintenance treatment
These ADM placebo substitution maintenance trials for youth with major depressive disorder (MDD) are characterized by high dropout rates, a rapid withdrawal that often can follow the switch to placebo, and relapse rates that are not dissimilar from those in the natural course of the disorder
This review initially presents a brief summary of the evidence from ADM short-term trials for youth diagnosed with MDD
Summary
Antidepressant treatment (ADM) is the second most common psychotropic therapy for U.S youth [1], and in recent years its treatment prevalence is increasing [2, 3]. Maintenance ADM treatment has its FDA support based on double-blind, placebo substitution trials of short-term ADM responders. Such trials are referred to as drug. In the only other fluoxetine response data from short-term ADM trials for youth diagnosed with MDD (published in 1997, 2002 and 2004), the placebo response rates ranged from 33% to 37% [16, 17]. 5) In a meta-analysis of published ADM efficacy trials of youth diagnosed with MDD, the average response rates from 1997 to 2010 were 62% for ADM and 52% for placebo [19]. 6) In summary, evidence supporting ADM efficacy for youth diagnosed with MDD has become increasingly limited These trials tend to have higher placebo responses
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