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Center for Global Research Data

Comparative efficacy and tolerability of new-generation antidepressants for major depressive disorder in children and adolescents: protocol of an individual patient data meta-analysis

Lead Investigator: Peng Xie, Chongqing Medical University
Title of Proposal Research: Comparative efficacy and tolerability of new-generation antidepressants for major depressive disorder in children and adolescents: protocol of an individual patient data meta-analysis
Vivli Data Request: 4324
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Major depressive disorder (MDD) is a commonly occurring serious mental disorder, accounting for a large portion of the global burden of disease. The overall prevalence rate of depressive disorder is about 3% in children and 6% in adolescents. Depressive disorder in youth is often associated with high rates of comorbid mental disorders, functional impairment and suicide. For young people aged 10–19 years, depressive disorders are the leading cause of health-related burden, accounting for 6–10% of the disability-adjusted life-years, which are the key metric used to assess the Global Burden of Disease (GBD).

Although previous studies have provided some important findings about pharmacological treatments for children and adolescents with depressive disorders in the past decades, several questions still remain unsolved by the aggregate data from those meta-analyses. Individual participant data meta-analysis (IPD-MA) enables exploration of the impacts of individual characteristics on treatment effects, allowing matching of treatments to specifc subgroups of patients. We will perform an IPD-MA to assess the effcacy and tolerability of new-generation antidepressants for major depressive disorder in children and adolescents.

Requested Studies:

A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
Sponsor: Eli Lilly and Company
Study ID: NCT00849693
Sponsor ID: 7109

A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
Sponsor: Eli Lilly and Company
Study ID: NCT00849901
Sponsor ID: 6223

A Randomised, Double-blind, Placebo Controlled, Parallel Group , Flexible Dose Study to Evaluate the Efficacy and Safety of Paxil® Tablets in Children and Adolescents With Major Depressive Disorder
Sponsor: GlaxoSmithKline
Study ID: NCT00812812
Sponsor ID: 112487

Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder
Data Contributor: Pfizer Inc.
Study ID: NCT01371734

Desvenlafaxine Versus Placebo in a Fluoxetine-Referenced Study of Children and Adolescents with Major Depressive Disorder
Data Contributor: Pfizer Inc.
Study ID: NCT01372150

A Multi-center, Double-blind, Placebo-Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression – Acute Phase
Sponsor: GlaxoSmithKline
Sponsor ID: BRL-029060/329: Acute Phase

A Multi-center, Double-blind, Placebo-Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression – Continuation Phase.
Sponsor: GlaxoSmithKline
Sponsor ID: 29060/329_1

A Double-blind, Multicentre Placebo-Controlled Study of Paroxetine in Adolescents with Unipolar Major Depression.
Sponsor: GlaxoSmithKline
Sponsor ID: BRL-029060/377

A multi-center, double blind, placebo-controlled flexible dose study to evaluate the efficacy and safety of Paroxetine in children with major depression.
Sponsor: GlaxoSmithKline
Sponsor ID: BRL-029060/701

Fluoxetine Versus Placebo in Childhood/Adolescent Depression (Relapse)
Sponsor: Eli Lilly and Company
Sponsor ID: B1Y-MC-HCJE

Fluoxetine Versus Placebo in Adolescent Depressed Patients
Sponsor: Eli Lilly and Company
Sponsor ID: B1Y-MC-HCCJ