At a glance
ClinicalIndex Comparison Record- ✓Meet DSM-IV criteria for Major Depressive Disorder
- ✓Current depressive episode duration of at least 12 weeks
- ✓Parent or caregiver willing to accompany patient to all clinic visits
- ✕Current diagnosis of ADHD, OCD, PTSD, bipolar disorder, pervasive developmental disorder, intellectual disability, conduct disorder, or oppositional defiant disorder
- ✕Active suicidal ideation, prior suicide attempt, or hospitalization for suicide risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Escitalopram and Placebo for Major Depressive Disorder. Completed, enrolled 312 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
Placebo once daily for up to 8 weeks