NCT00107120

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

A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
DRUG	Placebo	Placebo once daily for up to 8 weeks

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-05-01
• First posted: 2005-04-06
• Last updated: 2012-04-06
• Results posted: 2009-11-04

Locations

28 sites across 1 country: United States