What are the indications for Lexapro (escitalopram) in adults and adolescents?

Lexapro (Escitalopram) Indications

Lexapro is FDA-approved for the acute and maintenance treatment of major depressive disorder in adults and adolescents aged 12-17 years, and for the acute treatment of generalized anxiety disorder in adults only. 1

FDA-Approved Indications

Major Depressive Disorder (MDD)

• Approved for adults and adolescents 12-17 years of age for both acute treatment and maintenance therapy 1
• A major depressive episode requires a prominent and persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that interferes with daily functioning, plus at least five of nine DSM-IV symptoms including: depressed mood, loss of interest, significant weight/appetite change, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, guilt or worthlessness, impaired concentration, or suicidal ideation 1

Generalized Anxiety Disorder (GAD)

• Approved for adults only for acute treatment 1
• GAD is characterized by excessive anxiety and worry persistent for at least 6 months that is difficult to control, associated with at least 3 symptoms: restlessness, easy fatigue, difficulty concentrating, irritability, muscle tension, or sleep disturbance 1

Evidence Supporting Adolescent Use

Efficacy in Adolescents (Ages 12-17)

• Escitalopram demonstrated statistically significant superiority over placebo in adolescents with MDD, with mean CDRS-R score improvement of -22.1 versus -18.8 for placebo (p=0.022) after 8 weeks of treatment 2
• The American Academy of Child and Adolescent Psychiatry recognizes escitalopram as FDA-approved for adolescents aged 12-17 years with depression 3
• Escitalopram showed efficacy specifically in the 12-17 year age group but NOT in younger children, with moderate-strength evidence supporting this age-specific distinction 3

Safety Profile in Adolescents

• Escitalopram was generally well tolerated with 83% of patients completing 8 weeks of treatment 2
• Most common adverse events (≥10% incidence) were headache, menstrual cramps, insomnia, and nausea 2
• Discontinuation rates due to adverse events were low at 2.6% for escitalopram versus 0.6% for placebo 2
• Incidence of suicidality-related adverse events was similar between escitalopram and placebo groups 4, 2

Important Clinical Caveats

Age Restrictions

• Escitalopram is NOT approved for children under 12 years of age 3, 1
• Fluoxetine remains the only FDA-approved antidepressant for children as young as 8 years old 3

Bipolar Disorder Considerations

• Exercise caution when prescribing escitalopram to patients with family history of bipolar disorder, as SSRIs can destabilize mood or precipitate manic episodes in undiagnosed bipolar disorder 5
• Manic symptoms associated with an SSRI may represent unmasking of bipolar disorder or disinhibition secondary to the agent 5

Suicidality Monitoring

• Close monitoring for suicidal ideation and behavior is mandatory, especially during the first months of treatment and after dose adjustments, with FDA black box warning for increased suicidal thinking through age 24 3
• In-person assessment should occur within 1 week of treatment initiation 3

Adult Efficacy Data

• Escitalopram demonstrated superiority to placebo and was generally at least as effective as other SSRIs (citalopram, paroxetine, fluoxetine, sertraline) and SNRIs (duloxetine, venlafaxine) in adult MDD trials 6
• Long-term trials demonstrated greater efficacy than placebo in relapse prevention for adults 6