FDA-Approved Medications for Adolescent Depression
The two FDA-approved medications for treating major depressive disorder in adolescents are fluoxetine (approved for children and adolescents aged 8 years and older) and escitalopram (approved for adolescents aged 12 years and older). 1
FDA Approval Status
Fluoxetine is the only antidepressant with FDA approval for use in both children and adolescents with depression, making it the first-line choice when treating younger patients 1, 2
Escitalopram has FDA approval specifically for adolescents aged 12 years and older, not for younger children 1
All other SSRIs (citalopram, sertraline, paroxetine, fluvoxamine) lack FDA approval for pediatric depression, though they may be used off-label 1
Evidence Supporting These Medications
Fluoxetine has demonstrated efficacy in multiple randomized controlled trials:
- Two placebo-controlled trials confirmed its effectiveness for acute treatment of MDD in pediatric patients 3
- Response rates of 56% versus 33% for placebo in one major trial 4
- Superior efficacy when combined with cognitive-behavioral therapy (71% response rate) 5
Escitalopram showed efficacy specifically in adolescents:
- Demonstrated superiority to placebo in improving depression symptoms, symptom severity, and global functioning in adolescents 1
- However, it was NOT superior to placebo in children, highlighting the age-specific approval 1
Important Clinical Caveats
Regarding anxiety: Neither fluoxetine nor escitalopram has FDA approval specifically for anxiety disorders in adolescents—their approval is limited to major depressive disorder 1
Dosing considerations:
- Fluoxetine: Start at 10 mg daily, increase by 10-20 mg increments, effective dose 20 mg, maximum 60 mg 1
- Escitalopram: Start at 10 mg daily, increase by 5 mg increments, effective dose 10 mg, maximum 20 mg 1
Black box warning: All SSRIs carry FDA black-box warnings regarding increased suicidality risk in children and adolescents, requiring close monitoring especially during treatment initiation 1