Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Adolescents Escitalopram Pediatrics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 312
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks arm 2: Placebo once daily for up to 8 weeks

Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks intervention 2: Placebo once daily for up to 8 weeks

Protocol document: