The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder

Phase 3 Completed 312 enrolled Forest Laboratories

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.

Timeline

Start: 2005-03
Primary completion: 2007-05
Completion: —

Outcome

Met primary endpoint

registry analysis (superiority or other test); Escitalopram vs Placebo; p = 0.022; Least Square Means Difference -3.4 (95% CI -6.2 to -0.5); ANCOVA; NCT00107120 ↗

paper Significant improvement was seen in the escitalopram group relative to the placebo group at endpoint in CDRS-R score (-22.1 versus -18.8, p =.022; PMID 19465881 ↗

Publications

Results Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-729. doi: 10.1097/CHI.0b013e3181a2b304.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Escitalopram	Small molecule	10 mg	—
Subject	Escitalopram	Small molecule	20 mg	—