Center for Global Research Data

Efficacy of serotonin reuptake inhibitors in children and adolescents

Lead Investigator: Elias Eriksson, University of Gothenburg
Title of Proposal Research: Efficacy of serotonin reuptake inhibitors in children and adolescents
Vivli Data Request: 7479, 7075
Funding Source: None
Potential Conflicts of Interest: Professor Eriksson has previously been on advisory boards, received speaker’s honoraria, or research grants from H Lundbeck, Janssen-Cilag and Servier. These relationships do not pose a conflict of interest with regard to the current project. Dr. Hieronymus has previously received speaker’s fees from H Lundbeck and Servier. These relationships do not pose a conflict of interest with regard to the current research.

Summary of the Proposed Research:

The efficacy of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenaline reuptake inhibitors (SNRIs) in treating children and adolescents with depression is a controversial subject, and the impact of age and sex on treatment outcome is unclear. In most studies, patients are divided into age groups according to English nomenclature; children 7-11 years and adolescents 12-18 years, with no respect to pubertal stage or differential maturity between sexes. Little is also known about how individual items on the psychometric scales used in these studies respond to antidepressant therapy and placebo respectively, and if there are differences at baseline between different age groups. We have previously pointed out that in GlaxoSmithKline’s study GSK-BRL-029060/329, there was a significant effect on depressed mood, item 1 from the Hamilton Depression Rating Scale, as also reported by the original authors. Further, we showed that after excluding the youngest patients (<13 years of age), there was also a significant effect on the total score of the HDRS, the main outcome measure used. As SSRIs and SNRIs continue to be routinely used for depression in children and adolescents, the impact of age and sex on the efficacy of these compounds needs to be clarified.

Requested Studies:

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
Data Contributor: GlaxoSmithKline
Study ID: NCT00812812
Sponsor ID: 112487

Fluoxetine Versus Placebo in Adolescent Depressed Patients
Data Contributor: Lilly
Study ID: B1Y-MC-HCCJ
Sponsor ID: B1Y-MC-HCCJ

Fluoxetine Versus Placebo in Childhood/Adolescent Depression (Relapse)
Data Contributor: Lilly
Study ID: B1Y-MC-HCJE
Sponsor ID: B1Y-MC-HCJE

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER
Data Contributor: Pfizer Inc.
Study ID: NCT01372150
Sponsor ID: B2061014

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Data Contributor: Pfizer Inc.
Study ID: NCT01371734
Sponsor ID: B2061032

(Note: Additional studies added as part of Data Request 7479)

Fluoxetine Versus Placebo in the Acute Treatment of Major Depressive Disorder in Children and Adolescents
Data Contributor: Lilly
Study ID: B1Y-MC-X065
Sponsor ID: B1Y-MC-X065

Randomized, Double-Blind, Placebo-Controlled Trial of Vilazodone in Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up
Data Contributor: AbbVie
Study ID: NCT02372799
Sponsor ID: VLZ-MD-22

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder
Data Contributor: AbbVie
Study ID: NCT01878292
Sponsor ID: VLZ-MD-21