A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression

Title

A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression

Creator

Wagner KD; Jonas J; Findling RL; Ventura D; Saikali K

Publisher

Journal Of The American Academy Of Child And Adolescent Psychiatry

Date

2006

Subject

Child; Female; Humans; Male; Double-Blind Method; Depressive Disorder; Diagnostic and Statistical Manual of Mental Disorders; adolescent; Non-U.S. Gov't; Research Support; PedPal Lit; N.I.H.; Extramural; Citalopram/therapeutic use; Major/diagnosis/drug therapy; Serotonin Uptake Inhibitors/therapeutic use

Description

OBJECTIVE: Escitalopram is a selective serotonin reuptake inhibitor antidepressant indicated for use in adults. This trial examined the efficacy and safety of escitalopram in pediatric depression. METHOD: Patients (6-17 years old) with major depressive disorder were randomized to receive 8 weeks of double-blind flexibly dosed treatment with escitalopram (10-20 mg/day; n = 131) or placebo (n = 133). Randomization was not stratified by age. The primary efficacy measure was the mean change from baseline to endpoint in Children's Depression Rating Scale-Revised (CDRS-R) scores, using the last observation carried forward approach. RESULTS: A total of 82% of patients completed treatment. Escitalopram did not significantly improve CDRS-R scores compared to placebo at endpoint (least squares mean difference = -1.7, p = .31; last observation carried forward). In a post hoc analysis of adolescent (ages 12-17 years) completers, escitalopram significantly improved CDRS-R scores compared with placebo (least squares mean difference = -4.6, p = .047). Headache and abdominal pain were the only adverse events in >10% of patients in the escitalopram group. Discontinuation rates caused by adverse events were 1.5% for both groups. Potential suicide-related events were observed in one escitalopram- and two placebo-treated patients. There were no completed suicides. CONCLUSIONS: Although there were no significant differences between escitalopram and placebo in the total population, the data suggest that escitalopram may have beneficial effects in adolescent patients. Escitalopram appeared to be well tolerated.
2006

Rights

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

Type

Journal Article

Citation List Month

Backlog

Pages

280-8

Issue

3

Volume

45

Citation

Wagner KD; Jonas J; Findling RL; Ventura D; Saikali K, “A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression,” Pediatric Palliative Care Library, accessed September 20, 2021, https://pedpalascnetlibrary.omeka.net/items/show/13167.

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