drugset / Trial / NCT00107120

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

NCT00107120

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Escitalopram Small molecule 10 mg
Subject Escitalopram Small molecule 20 mg