Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial
Open accessAbstract
Objective This article presents the results from a prospective, randomized, double-blind, placebo-controlled trial of escitalopram in adolescent patients with major depressive disorder. Method Male and female adolescents (aged 12-17 years) with DSM-IV-defined major depressive disorder were randomly assigned to 8 weeks of double-blind treatment with escitalopram 10 to 20 mg/day (n = 155) or placebo (n = 157). The primary efficacy parameter was change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score using the last observation carried forward approach. Results A total of 83% patients (259/312) completed 8 weeks of double-blind treatment. Mean CDRS-R score at baseline was 57.6 for escitalopram and 56.0 for placebo. Significant improvement was seen in the escitalopram group relative to the placebo group at endpoint in CDRS-R score (-22.1 versus -18.8, p =.022; last observation carried forward). Adverse events occurring in at least 10% of escitalopram patients were headache, menstrual cramps, insomnia, and nausea; only influenza-like symptoms occurred in at least 5% of escitalopram patients and at least twice the incidence of placebo (7.1% versus 3.2%). Discontinuation rates due to adverse events were 2.6% for escitalopram and 0.6% for placebo. Serious adverse events were reported by 2.6% and 1.3% of escitalopram and placebo patients, respectively, and incidence of suicidality was similar for both groups. Conclusions In this study, escitalopram was effective and well tolerated in the treatment of depressed adolescents.
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In Study 2, the characteristics of the validation sample were similar to the baseline characteristics of the total sample.
“The characteristics of the validation sample were similar to the baseline characteristics of the total sample (37).”
From The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults (2011) · cites this paper as [37]
Escitalopram's efficacy as an antidepressant has not been demonstrated in patients under the age of 12 years.
“We did not select escitalopram because its efficacy as an antidepressant has not been demonstrated in patients under the age of 12 years [167, 168]”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [167]
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Self-citation
- Authors
- Emslie, G. J., Ventura, D., Korotzer, A., & Tourkodimitris, S.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Corresponding author
- Emslie, Graham J.
- ORCID
- Emslie, Graham J.
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2009-07
- Volume
- 48
- Issue
- 7
- Pages
- 721-729
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2003027810
- Cited by
- 210
- References
- 23
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 14 · 2023: 12 · 2022: 17 · 2021: 12 · 2020: 10 · 2019: 16 · 2018: 11 · 2017: 9 · 2016: 11 · 2015: 5 · 2014: 9 · 2013: 17 · 2012: 16
- FWCI
- 10.29
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- escitalopram, adolescent depression, major depressive disorder, selective serotonin reuptake inhibitors, antidepressant efficacy, drug tolerability, adverse events, suicidality, Children's Depression Rating Scale-Revised
- MeSH terms
- Adolescent, Child, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Patient Dropouts, Personality Assessment, Prospective Studies, Psychometrics, Citalopram, Adverse Drug Reaction Reporting Systems, Antidepressive Agents, Second-Generation
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