Fluoxetine versus placebo in preventing relapse of major depression in children and adolescents.
OBJECTIVE
The authors compared fluoxetine and placebo in continuation treatment to prevent relapse of major depressive disorder in children and adolescents.


METHODS
After a detailed evaluation, children and adolescents 7-18 years of age with major depressive disorder were treated openly with fluoxetine. Those who had an adequate response after 12 weeks, as indicated by a Clinical Global Impression improvement score of 1 or 2 and a decrease of at least 50% in Children's Depression Rating Scale-Revised score, were randomly assigned to receive fluoxetine or placebo for an additional 6 months. The primary outcome measures were relapse and time to relapse. Relapse was defined as either a score of 40 or higher on the Children's Depression Rating Scale with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. Additional analyses were conducted with relapse defined only as a score of 40 or higher on the Children's Depression Rating Scale.


RESULTS
Of 168 participants enrolled in acute fluoxetine treatment, 102 were randomly assigned to continuation treatment with fluoxetine (N=50) or placebo (N=52). Of these, 21 participants (42.0%) in the fluoxetine group relapsed, compared with 36 (69.2%) in the placebo group, a significant difference. Similarly, under the stricter definition of relapse, fewer participants in the fluoxetine group relapsed (N=11; 22.0%) than in the placebo group (N=25; 48.1%). Time to relapse was significantly shorter in the placebo group.


CONCLUSIONS
Continuation treatment with fluoxetine was superior to placebo in preventing relapse and in increasing time to relapse in children and adolescents with major depression.
Emslie
Graham J
GJ
University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-8589, USA. graham.emslie@utsouthwestern.edu
Kennard
Beth D
BD
Mayes
Taryn L
TL
Nightingale-Teresi
Jeanne
J
Carmody
Thomas
T
Hughes
Carroll W
CW
Rush
A John
AJ
Tao
Rongrong
R
Rintelmann
Jeanne W
JW
D000293:Adolescent; D000367:Age Factors; D002648:Child; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010919:Placebos; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors