A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents

Karen Wagner, Adelaide S. Robb, Robert L. Findling, Jianqing Jin, Marcelo M. Gutierrez, William E. Heydorn

Research output: Contribution to journalArticle

240 Citations (Scopus)

Abstract

Objective: Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective and safe for the treatment of depressive symptoms in children and adolescents. The current study investigated the efficacy and safety of citalopram compared with placebo in the treatment of pediatric patients with major depression. Method: An 8-week, randomized, double-blind, placebo-controlled study compared the safety and efficacy of citalopram with placebo in the treatment of children (ages 7-11) and adolescents (ages 12-17) with major depressive disorder. Diagnosis was established with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version. Patients (N=174) were treated initially with placebo or 20 mg/day of citalopram, with an option to increase the dose to 40 mg/day at week 4 if clinically indicated. The primary outcome measure was score on the Children's Depression Rating Scale-Revised; the response criterion was defined as a score of ≤28. Results: The overall mean citalopram dose was approximately 24 mg/day. Mean Children's Depression Rating Scale-Revised scores decreased significantly more from baseline in the citalopram treatment group than in the placebo treatment group, beginning at week 1 and continuing at every observation point to the end of the study (effect size=2.9). The difference in response rate at week 8 between placebo (24%) and citalopram (36%) also was statistically significant. Citalopram treatment was well tolerated. Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups (5.9% versus 5.6%, respectively). Rhinitis, nausea, and abdominal pain were the only adverse events to occur with a frequency exceeding 10% in either treatment group. Conclusions: In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated.

Original languageEnglish (US)
Pages (from-to)1079-1083
Number of pages5
JournalAmerican Journal of Psychiatry
Volume161
Issue number6
DOIs
StatePublished - Jun 2004

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Citalopram
Randomized Controlled Trials
Placebos
Depression
Therapeutics
Safety
Major Depressive Disorder
Serotonin Uptake Inhibitors
Rhinitis
Mood Disorders
Nausea
Abdominal Pain
Schizophrenia
Appointments and Schedules
Observation
Outcome Assessment (Health Care)
Pediatrics

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. / Wagner, Karen; Robb, Adelaide S.; Findling, Robert L.; Jin, Jianqing; Gutierrez, Marcelo M.; Heydorn, William E.

In: American Journal of Psychiatry, Vol. 161, No. 6, 06.2004, p. 1079-1083.

Research output: Contribution to journalArticle

Wagner, Karen ; Robb, Adelaide S. ; Findling, Robert L. ; Jin, Jianqing ; Gutierrez, Marcelo M. ; Heydorn, William E. / A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. In: American Journal of Psychiatry. 2004 ; Vol. 161, No. 6. pp. 1079-1083.
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