A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Escitalopram
- Conditions
- Major Depressive Disorder
- Sponsor
- Forest Laboratories
- Enrollment
- 312
- Locations
- 28
- Primary Endpoint
- Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- •Patient's current depressive episode must be at least 12 weeks in duration
- •Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
Exclusion Criteria
- •Patients who currently meet DSM-IV criteria for:
- •attention deficit-hyperactivity disorder
- •obsessive-compulsive disorder
- •posttraumatic stress disorder
- •bipolar disorder
- •pervasive developmental disorder
- •mental retardation
- •conduct disorder
- •oppositional defiant disorder
- •Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
Arms & Interventions
Escitalopram
Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
Intervention: Escitalopram
2
Placebo once daily for up to 8 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Time Frame: Baseline to end of week 8
Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.
Secondary Outcomes
- Clinical Global Impressions - Improvement(CGI-I score at the end of Week 8)