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Evaluating predictors of antidepressant response or remission in children and adolescents with depression








Evaluating predictors of antidepressant response or remission in children and adolescents with depression


O'Mareen Spence, MPH


University of Maryland Baltimore, School of Pharmacy, Pharmaceutical Health Services Research Department






11 December 2018


Depression is a common serious mental disorder in youth, with an estimated prevalence of 3% in children and 12% in adolescents. In randomized controlled trials, evidence supporting the efficacy of antidepressants in youth with depression is strongest for SSRIs, particularly fluoxetine. However, at least 40% of youth do not respond to first line antidepressant treatment. Augmenting antidepressant is one recommended approach for treating youth who do not respond to an adequate trial of an initial antidepressant. However, with child and adolescent depression treatment in community settings youth either a) early augmentation following inadequate dose and duration of antidepressant therapy or b) after prolonged use with no improvement. The problem is that prolonged period of antidepressant treatment in youth unlikely to respond increases the risk of worsening depression and suicide, and early augmentation in youth who are likely to respond increases the risk of psychotropic overuse. The overall goal of this project is to evaluate antidepressant treatment response in outpatient community settings and its association with treatment augmentation. Our first step is to predict antidepressant treatment response as a function of early symptom improvement, dose and baseline characteristics We will use individual patient data (IPD) from the duloxetine (LILLY-F1J-MC-HMCK & LILLY-F1J-MC-HMCL), fluoxetine (LILLY-B1Y-MC-HCJE) and paroxetine (29060/377,029060/701 & GSK-BRL-029060/329) clinical trials to evaluate subject-specific duloxetine, fluoxetine and paroxetine weekly dosing, and to identify predictors of antidepressant response and remission.



[{ "PostingID": 1280, "Title": "GSK-BRL-029060/329: Acute Phase", "Description": "A Multi-center, Double-blind, Placebo-Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression - Acute Phase" },{ "PostingID": 1632, "Title": "GSK-BRL-029060/377", "Description": "A Double-blind, Multicentre Placebo-Controlled Study of Paroxetine in Adolescents with Unipolar Major Depression." },{ "PostingID": 1637, "Title": "GSK-BRL-029060/701", "Description": "A multi-center, double blind, placebo-controlled flexible dose study to evaluate the efficacy and safety of Paroxetine in children with major depression." },{ "PostingID": 2833, "Title": "LILLY-F1J-MC-HMCK", "Description": "A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder" },{ "PostingID": 2834, "Title": "LILLY-F1J-MC-HMCL", "Description": "A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder" },{ "PostingID": 3151, "Title": "GSK-BRL-029060/716", "Description": "A Multi-center, Open-label, Six-Month Extension Study to Assess the Long-term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive Compulsive Disorder (OCD)" },{ "PostingID": 17515, "Title": "LILLY-B1Y-MC-HCJE", "Description": "Fluoxetine Versus Placebo in Childhood/Adolescent Depression (Relapse)" }]

Statistical Analysis Plan