Antidepressants in children and adolescents with Major Depressive Disorder and the influence of placebo response: a meta-analysis

Lead Investigator: Anna Feeney, Massachusetts General Hospital
Title of Proposal Research: Antidepressants in children and adolescents with Major Depressive Disorder and the influence of placebo response: a meta-analysis
Vivli Data Request: 6641
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Major Depressive Disorder (MDD) or ‘depression’ affects many children and adolescents in the United States (US). In 2018, 14.4% of adolescents aged 12 to 17 years in the US were estimated to have had an episode of depression in the past year, a proportion that has been rising over the past two decades. Many antidepressant clinical trials fail in pediatric populations. Obstacles to the development of MDD treatments include the placebo response (patients responding to an inactive substance rather than the drug being studied) and measurement error (the difference between the true value and the measured value) in studies of MDD. Our group’s previous work has identified that in studies of adult MDD, a greater likelihood of receiving placebo predicts a greater antidepressant-placebo separation at study endpoint (demonstration of a difference between the drug and placebo at the end of the study). A high placebo response rate in pediatric MDD studies is widely reported. The purpose of this work is to review studies of antidepressants in children and adolescents with MDD, and to better understand the contribution of the placebo response to the findings of these studies.

Requested Studies:

A MULTICENTER 10-WEEK RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED FLEXIBLE DOSE OUTPATIENT STUDY OF SERTRALINE IN CHILDREN AND ADOLESCENTS WITH MAJOR DEPRESSIVE DISORDER
Data Contributor: Pfizer
Sponsor ID: A0501001

A MULTICENTER 10-WEEK RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED FLEXIBLE DOSE OUTPATIENT STUDY OF SERTRALINE IN CHILDREN AND ADOLESCENTS WITH MAJOR DEPRESSIVE DISORDER
Data Contributor: Pfizer
Sponsor ID: A0501017

Update: This data request was withdrawn on 16-Aug-2021 by the researcher.