NCT01198795

Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram	Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2010-09-10
• Last updated: 2014-03-14
• Results posted: 2014-03-14

Locations

16 sites across 1 country: United States