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Selective Serotonin Reuptake Inhibitors (SSRIs): Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents including a summary of available safety and efficacy data

Level 1 - Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents

Introduction
We have arranged this section into three levels of detail which we hope you will find useful:

 Level 1: Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents.
Level 2: Summary of available safety and efficacy data in MDD in children and adolescents.
 Level 3: Summary of clinical trials relating to MDD in children and adolescents

Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents

Fluoxetine Sertraline Citalopram Escitalopram Fluvoxamine Paroxetine Venlafaxine Mirtazapine

Drug class

SSRI

SSRI

SSRI

SSRI (active constituent of citalopram)

SSRI

SSRI

Serotonin and noradrenaline reuptake inhibitor (SNRI)

Noradrenergic and specific serotonergic antidepressant

Licensed indications children and adolescents

None

Obsessive compulsive disorder

None

None

Obsessive compulsive disorder

None

None

None

Efficacy in major depressive disorder (MDD) in children and adolescents

Demonstrated in controlled clinical trials

Not demonstrated in controlled clinical trials

Not consistently demonstrated in controlled clinical trials

No data from clinical trials

No data from clinical trials

Not demonstrated in controlled clinical trials

Not demonstrated in controlled clinical trials

Not demonstrated in controlled clinical trials

Safety profile in MDD trials in children and adolescents

Mania and hypomania more frequently reported than in adults, perhaps as a result of differing inclusion criteria in clinical trials. No increased rate of self-harm and suicidal thoughts compared with placebo

Rate of events including agitation, anorexia, insomnia and suicidal thoughts and self harm increased compared with placebo

Increased rate of self-harm compared with placebo in 1 of 2 trials

No data from clinical trials

No data from clinical trials

Increased rate of self-harm and suicidal thoughts compared with placebo

Increased rate of self-harm and suicidal thoughts compared with placebo

No increased rate of self-harm and suicidal thoughts compared with placebo

CSM advice in relation to MDD in children and adolescents

Risk/benefit balance is favourable

Risk/benefit balance is unfavourable

Risk/benefit balance is unfavourable

Risk/benefit balance is presumed unfavourable. (Extrapolation from citalopram.)

Risk/benefit balance is not assessable - safety and efficacy in adults cannot be extrapolated to under 18 year olds

Risk/benefit balance is unfavourable

Risk/benefit balance is unfavourable

Risk/benefit balance is unfavourable

 

 

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Page last modified: 10 December 2003