Lexapro (escitalopram) - 2 indications

Scroll down for more information on each indication:

• for the treatment of major depressive disorder in adults and adolescents; approved August 2002
• for the treatment of generalized anxiety disorder; approved December 2003

General Information

Lexapro (escitalopram) is an orally administered selective serotonin reuptake inhibitor (SSI).

Lexapro is specifically indicated for:

• the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age
• the acute treatment of Generalized Anxiety Disorder (GAD) in adults

Lexapro is supplied as tablets and an oral solution. Scroll down for the recommended dosing/administration for each indication.

Mechanism of Action

Lexapro (escitalopram) is a selective serotonin reuptake inhibitor (SSI). The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

Side Effects

Adverse events associated with the use Lexapro may include (but are not limited to) the following:

• nausea
• insomnia
• fatigue
• somnolence
• sweating increased
• ejaculation disorder

The Lexapro drug label comes with the following Black Box Warning: Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Lexapro is not approved for use in pediatric patients less than 12 years of age.

Indication 1 - for the treatment of major depressive disorder in adults and adolescents

approved August 2002

Dosing/Administration

Initial Treatment

Adolescents

• The recommended dose of Lexapro is 10 mg once daily. A flexible-dose trial of Lexapro (10 to 20 mg/day) demonstrated the effectiveness of Lexapro. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.

Adults

• The recommended dose of Lexapro is 10 mg once daily. A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Maintenance Treatment

• It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing Lexapro 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking Lexapro during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment. Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.

Clinical Trial Results

Lexapro's approval was based on a double-bind, placebo-controlled, multi-center study that involved 491 subjects with ongoing major depressive episodes. The subjects were randomized for eight weeks to one of four trial arms: placebo, Lexapro at 10 mg per day, Lexapro at 20 mg per day, or Celexa at 40 mg per day. The results showed that Lexapro at 10 mg per day and 20 mg per day demonstrated significantly greater improvement relative to placebo. Additionally, Lexapro 10 mg was shown to be as effective as 40 mg of Celexa on the major efficacy outcome variables. Summarily, Lexapro was statistically superior to placebo in all common efficacy measures, beginning at week one and continuing throughout the study period. All treatment groups had a low rate of discontinuation due to adverse events.

Adolescents

The efficacy of Lexapro as an acute treatment for major depressive disorder in adolescent patients was established in an 8-week, flexible-dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in outpatients 12 to 17 years of age inclusive who met DSM-IV criteria for major depressive disorder. The primary outcome was change from baseline to endpoint in the Children’s Depression Rating Scale - Revised (CDRS-R). In this study, Lexapro showed statistically significant greater mean improvement compared to placebo on the CDRS-R. The efficacy of Lexapro in the acute treatment of major depressive disorder in adolescents was established, in part, on the basis of extrapolation from the 8-week, flexible-dose, placebo-controlled study with racemic citalopram 20-40 mg/day. In this outpatient study in children and adolescents 7 to 17 years of age who met DSM-IV criteria for major depressive disorder, citalopram treatment showed statistically significant greater mean improvement from baseline, compared to placebo, on the CDRS-R; the positive results for this trial largely came from the adolescent subgroup.

Indication 2 - for the treatment of generalized anxiety disorder

approved December 2003

Dosing/Administration

Initial Treatment

• The recommended starting dose of Lexapro is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a mi nimum of one week.

Maintenance Treatment

• Generalized anxiety disorder is recognized as a chronic condition. The efficacy of Lexapro in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Clinical Trial Results

The efficacy of Lexapro in the acute treatment of Generalized Anxiety Disorder (GAD) was demonstrated in three, 8-week, multicenter, flexible-dose, placebo controlled studies that compared Lexapro 10-20 mg/day to placebo in adult outpatients between 18 and 80 years of age who met DSM-IV criteria for GAD. In all three studies, Lexapro showed statistically significant greater mean improvement compared to placebo on the Hamilton Anxiety Scale (HAM-A).