Is sertraline (selective serotonin reuptake inhibitor) approved for use in adolescents with major depressive disorder?

Sertraline FDA Approval Status in Adolescents with Major Depressive Disorder

Sertraline is NOT FDA-approved for major depressive disorder in adolescents, but it IS FDA-approved for obsessive-compulsive disorder (OCD) in pediatric patients aged 6 years and older. 1

FDA-Approved SSRIs for Adolescent Depression

Only two SSRIs have FDA approval specifically for major depressive disorder in the pediatric population:

• Fluoxetine: Approved for children aged 8 years and older with MDD 2
• Escitalopram: Approved for adolescents aged 12 to 17 years with MDD 2

Clinical Evidence Supporting Sertraline Use Despite Lack of FDA Approval

While sertraline lacks FDA approval for adolescent MDD, substantial clinical evidence supports its efficacy and safety:

Efficacy Data

• Sertraline demonstrated statistically significant superiority over placebo in adolescent MDD trials, with a 63% response rate versus 53% for placebo (p=0.05). 2
• Pooled analysis of two randomized controlled trials (n=376 patients aged 6-17 years) showed sertraline-treated patients had significantly greater improvement on depression rating scales compared to placebo (p=0.001). 3
• Based on a 40% decrease in depression scores, 69% of sertraline-treated patients were responders compared to 59% of placebo patients (p=0.05). 3

Long-term Safety Profile

• The FDA label confirms that approximately 600 pediatric patients between 6 and 17 years of age have received sertraline in clinical trials, with an adverse event profile generally similar to adults. 1
• Long-term data (24 weeks) showed 86% of patients met responder criteria and 58% achieved remission, with continued improvement beyond the initial 10 weeks. 4
• Sertraline was well tolerated with most adverse events being mild to moderate, including diarrhea, vomiting, anorexia, and agitation. 3

Clinical Practice Implications

Despite lacking specific FDA approval for adolescent MDD, sertraline is widely used and supported by clinical guidelines as an effective treatment option. 2

Key Considerations

• All SSRIs, including sertraline, carry a boxed warning for suicidal thinking and behavior through age 24 years. 2, 1
• The pooled absolute risk for suicidal ideation is 1% with antidepressants versus 0.2% with placebo, yielding a number needed to harm of 143 compared to a number needed to treat of 3. 2
• Close monitoring for suicidality is essential, especially during the first months of treatment and following dosage adjustments. 2, 1

Weight Monitoring

• Weight loss has been observed with sertraline use in pediatric patients, with approximately 7% of children experiencing >7% body weight loss compared to none on placebo. 1
• Regular monitoring of weight and growth is recommended if long-term treatment is continued. 1

Bottom Line for Clinical Practice

Fluoxetine remains the first-line SSRI for adolescent MDD based on FDA approval and the strongest evidence base. 2 However, sertraline represents a reasonable and evidence-supported alternative when fluoxetine is not tolerated or contraindicated, despite its off-label status for this indication. 5 The decision to use sertraline should include informed consent discussion with patients and families regarding its off-label use for MDD while emphasizing its FDA approval for OCD in this age group. 1