Phase 3 Completed N=312 Randomized Quadruple-blind Treatment

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

Major Depressive Disorder

Source: ClinicalTrials.gov NCT00107120 ↗

Enrolled (actual)

312

Serious AEs

1.9%

Results posted

Nov 2009

Primary outcomePrimary: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score — -22.4; -18.4 Change in total score at endpoint — p=0.022

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score	-22.4; -18.4	0.022 sig
SECONDARY Clinical Global Impressions - Improvement	2.2; 2.5	0.008 sig

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.

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Data sourced from ClinicalTrials.gov (NCT00107120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.