What is the FDA-approved medication for severe anxiety and depression in a 16-year-old boy?

FDA-Approved Medications for Severe Anxiety and Depression in a 16-Year-Old Boy

For depression, fluoxetine is the only FDA-approved antidepressant for adolescents, while escitalopram is FDA-approved for anxiety in adolescents aged 12 and older. 1, 2

Depression Treatment

First-Line Medication

• Fluoxetine is the sole FDA-approved SSRI for treating major depressive disorder in children and adolescents aged 8 years and older. 1, 2
• Start at 10 mg daily, increase by 10-20 mg increments to an effective dose of 20 mg, with a maximum of 60 mg daily. 1
• Escitalopram has FDA approval for adolescents aged 12 and older for depression: start at 10 mg daily, increase by 5 mg increments to an effective dose of 10 mg, with a maximum of 20 mg daily. 1

Alternative SSRIs (Off-Label)

If fluoxetine or escitalopram are ineffective or not tolerated, consider these off-label options with informed consent: 1

• Sertraline: Start 25 mg daily, increase by 12.5-25 mg to effective dose of 50 mg (maximum 200 mg). 1
• Citalopram: Start 10 mg daily, increase by 10 mg to effective dose of 20 mg (maximum 60 mg). 1
• Paroxetine is NOT recommended to be started in primary care settings. 1

Anxiety Treatment

First-Line Medication

• For anxiety disorders (social anxiety, generalized anxiety, separation anxiety, panic disorder), SSRIs are recommended, though none have specific FDA approval for anxiety in this age group. 1
• The American Academy of Child and Adolescent Psychiatry recommends fluoxetine as first-line for pediatric anxiety disorders based on efficacy and safety profile. 3
• Duloxetine (SNRI) is the only medication with FDA indication for generalized anxiety disorder in children aged 7 and older, making it an option if SSRIs fail. 3

Dosing Strategy for Anxiety

• Use the same SSRI dosing as for depression, but expect a logarithmic response: statistically significant improvement by week 2, clinically significant improvement by week 6, and maximal improvement by week 12 or later. 1
• Start low and titrate slowly to avoid exceeding optimal dose. 1

Combined Anxiety and Depression

When both conditions are present, fluoxetine addresses both, as it has demonstrated efficacy for mixed anxiety disorders in adolescents. 4, 5

Critical Safety Monitoring

Black Box Warning Requirements

• All SSRIs carry an FDA black box warning for suicidal thinking and behavior through age 24 years. 1, 2
• The pooled absolute rate for suicidal ideation is 1% with antidepressants versus 0.2% with placebo in youth. 1
• Assess the patient in person within 1 week of starting medication, then monitor closely during the first few months and at any dose changes. 1

What to Monitor at Each Visit

At every assessment, evaluate: 1

1. Ongoing depressive/anxiety symptoms
2. Suicide risk
3. Adverse effects (behavioral activation, agitation, mania, gastrointestinal symptoms, sleep disturbances)
4. Treatment adherence
5. New or ongoing environmental stressors

Starting Dose Precautions

• Never start at higher than recommended starting doses—this increases deliberate self-harm and suicide risk. 1
• Most adverse effects emerge within the first few weeks and include nausea, headache, insomnia, nervousness, and appetite changes. 1

Medications to Avoid

• Tricyclic antidepressants have an unfavorable risk-benefit profile in adolescents. 1, 3
• Benzodiazepines should be avoided as primary treatment due to dependence risk and potential disinhibition. 3
• Paroxetine is not recommended for pediatric anxiety or depression. 3

Treatment Duration

• Continue medication for at least 1 year after response to prevent relapse, as the greatest relapse risk occurs in the first 8-12 weeks after discontinuation. 1
• Always taper SSRIs slowly when discontinuing to avoid withdrawal effects. 1

Common Pitfalls to Avoid

• Failing to provide thorough psychoeducation to both patient and parents about expected benefits, timeline of response, and potential risks before starting medication. 3
• Inadequate monitoring frequency, particularly in the first month of treatment. 3
• Stopping medication abruptly rather than tapering. 1
• Using doses that are too high initially or escalating too rapidly. 1