Fluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial

Graham J. Emslie, John H. Heiligenstein, Karen Wagner, Sharon L. Hoog, Daniel E. Ernest, Eileen Brown, Mary Nilsson, Jennie G. Jacobson

Research output: Contribution to journalArticle

431 Citations (Scopus)

Abstract

Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD (DSM-IV) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week (p < .05) and throughout the study period. Significantly more fluoxetine-treated patients (41%) met the prospectively defined criteria for remission than did placebo-treated patients (20%) (p < .01). More fluoxetine- (65%) than placebo-treated (53%) patients met the prospectively defined response criterion of ≥30% decrease in CDRS-R score, but this difference was not significant (p = .093). Significantly more fluoxetine- than placebo-treated patients completed acute treatment (p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events (p = .408). Conclusion: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

Original languageEnglish (US)
Pages (from-to)1205-1215
Number of pages11
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume41
Issue number10
DOIs
StatePublished - Oct 2002

Fingerprint

Fluoxetine
Randomized Controlled Trials
Placebos
Depression
Major Depressive Disorder
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
Antidepressive Agents
Outpatients
Clinical Trials
Pediatrics

Keywords

  • Fluoxetine
  • Major depressive disorder
  • Selective serotonin reuptake inhibitor

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Fluoxetine for Acute Treatment of Depression in Children and Adolescents : A Placebo-Controlled, Randomized Clinical Trial. / Emslie, Graham J.; Heiligenstein, John H.; Wagner, Karen; Hoog, Sharon L.; Ernest, Daniel E.; Brown, Eileen; Nilsson, Mary; Jacobson, Jennie G.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 41, No. 10, 10.2002, p. 1205-1215.

Research output: Contribution to journalArticle

Emslie, Graham J. ; Heiligenstein, John H. ; Wagner, Karen ; Hoog, Sharon L. ; Ernest, Daniel E. ; Brown, Eileen ; Nilsson, Mary ; Jacobson, Jennie G. / Fluoxetine for Acute Treatment of Depression in Children and Adolescents : A Placebo-Controlled, Randomized Clinical Trial. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2002 ; Vol. 41, No. 10. pp. 1205-1215.
@article{a168ed4bea4049dfa734fbb7442ee531,
title = "Fluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial",
abstract = "Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD (DSM-IV) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week (p < .05) and throughout the study period. Significantly more fluoxetine-treated patients (41{\%}) met the prospectively defined criteria for remission than did placebo-treated patients (20{\%}) (p < .01). More fluoxetine- (65{\%}) than placebo-treated (53{\%}) patients met the prospectively defined response criterion of ≥30{\%} decrease in CDRS-R score, but this difference was not significant (p = .093). Significantly more fluoxetine- than placebo-treated patients completed acute treatment (p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events (p = .408). Conclusion: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.",
keywords = "Fluoxetine, Major depressive disorder, Selective serotonin reuptake inhibitor",
author = "Emslie, {Graham J.} and Heiligenstein, {John H.} and Karen Wagner and Hoog, {Sharon L.} and Ernest, {Daniel E.} and Eileen Brown and Mary Nilsson and Jacobson, {Jennie G.}",
year = "2002",
month = "10",
doi = "10.1097/00004583-200210000-00010",
language = "English (US)",
volume = "41",
pages = "1205--1215",
journal = "Journal of the American Academy of Child and Adolescent Psychiatry",
issn = "0890-8567",
publisher = "Elsevier Limited",
number = "10",

}

TY - JOUR

T1 - Fluoxetine for Acute Treatment of Depression in Children and Adolescents

T2 - A Placebo-Controlled, Randomized Clinical Trial

AU - Emslie, Graham J.

AU - Heiligenstein, John H.

AU - Wagner, Karen

AU - Hoog, Sharon L.

AU - Ernest, Daniel E.

AU - Brown, Eileen

AU - Nilsson, Mary

AU - Jacobson, Jennie G.

PY - 2002/10

Y1 - 2002/10

N2 - Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD (DSM-IV) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week (p < .05) and throughout the study period. Significantly more fluoxetine-treated patients (41%) met the prospectively defined criteria for remission than did placebo-treated patients (20%) (p < .01). More fluoxetine- (65%) than placebo-treated (53%) patients met the prospectively defined response criterion of ≥30% decrease in CDRS-R score, but this difference was not significant (p = .093). Significantly more fluoxetine- than placebo-treated patients completed acute treatment (p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events (p = .408). Conclusion: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

AB - Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD (DSM-IV) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week (p < .05) and throughout the study period. Significantly more fluoxetine-treated patients (41%) met the prospectively defined criteria for remission than did placebo-treated patients (20%) (p < .01). More fluoxetine- (65%) than placebo-treated (53%) patients met the prospectively defined response criterion of ≥30% decrease in CDRS-R score, but this difference was not significant (p = .093). Significantly more fluoxetine- than placebo-treated patients completed acute treatment (p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events (p = .408). Conclusion: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

KW - Fluoxetine

KW - Major depressive disorder

KW - Selective serotonin reuptake inhibitor

UR - http://www.scopus.com/inward/record.url?scp=0036782909&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036782909&partnerID=8YFLogxK

U2 - 10.1097/00004583-200210000-00010

DO - 10.1097/00004583-200210000-00010

M3 - Article

C2 - 12364842

AN - SCOPUS:0036782909

VL - 41

SP - 1205

EP - 1215

JO - Journal of the American Academy of Child and Adolescent Psychiatry

JF - Journal of the American Academy of Child and Adolescent Psychiatry

SN - 0890-8567

IS - 10

ER -