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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