TY - JOUR
T1 - A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression
AU - Emslie, Graham J.
AU - John Rush, A.
AU - Weinberg, Warren A.
AU - Kowatch, Robert A.
AU - Hughes, Carroll W.
AU - Carmody, Tom
AU - Rintelmann, Jeanne
N1 - Funding Information:
Acceptedfor publication August 20, 1996. This study was supported by grants MH-39188 (Dr Emslie) andMH-41115(DepartmentofPsychiatry,Uni¬ versityofTexasSouthwesternMedicalCenteratDallas)from theNationalInstituteofMentalHealth,NationalInstitutes ofHealth, Bethesda, Md. EvaluationUnitPresentedinpartattheannualNewClinicalDrugand Meeting, Orlando, Fla,June2, 1995, theAnnualMeetingoftheAmericanAcademy ofChild& AdolescentPsychiatry,NewOrleans,La,October19,1995. WethankKennethZ.Altshuler,MD,StantonSharpDis¬ tinguished Chair and Chairman, Department ofPsychiatry, forhisadministrativesupport;thestaffoftheChildandAdo¬ lescentPsychiatryServiceatChildren'sMedicalCenterfortheir clinicalassistance;MelodyBrummettjorhersecretarialsup¬ port; and Christina Gullion, PhD,fordesign, management of therandomizationprocedures,anddatamanagementadvice. Reprints: Graham J. Emslie, MD, Department of Psy¬ chiatry,UniversityofTexasSouthwesternMedicalCenterat Dallas,5323HarryHinesBlvd,Dallas,TX75235-9070.
PY - 1997
Y1 - 1997
N2 - Background: Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. Method: Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale-Revised, a measure of the severity depressive symptoms. Results: Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated 'much' or 'very much' improved on the Clinical Global Impressions scale at study exit (χ2=5.1, df=1, P=.02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale-Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n=48) and those aged 13 years and older (n=48). However, complete symptom remission (Children's Depression Rating Scale-Revised ≤28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. Conclusion: Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.
AB - Background: Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. Method: Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale-Revised, a measure of the severity depressive symptoms. Results: Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated 'much' or 'very much' improved on the Clinical Global Impressions scale at study exit (χ2=5.1, df=1, P=.02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale-Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n=48) and those aged 13 years and older (n=48). However, complete symptom remission (Children's Depression Rating Scale-Revised ≤28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. Conclusion: Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.
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U2 - 10.1001/archpsyc.1997.01830230069010
DO - 10.1001/archpsyc.1997.01830230069010
M3 - Article
C2 - 9366660
AN - SCOPUS:1842413623
SN - 0003-990X
VL - 54
SP - 1031
EP - 1037
JO - Archives of General Psychiatry
JF - Archives of General Psychiatry
IS - 11
ER -