Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial.
OBJECTIVE
To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression.


METHODS
After a 7- to 14-day screening period, 275 adolescents with major depression began 8 weeks of double-blind paroxetine (20-40 mg), imipramine (gradual upward titration to 200-300 mg), or placebo. The two primary outcome measures were endpoint response (Hamilton Rating Scale for Depression [HAM-D] score < or = 8 or > or = 50% reduction in baseline HAM-D) and change from baseline HAM-D score. Other depression-related variables were (1) HAM-D depressed mood item; (2) depression item of the Schedule for Affective Disorders and Schizophrenia for Adolescents-Lifetime version (K-SADS-L); (3) Clinical Global Impression (CGI) improvement scores of 1 or 2; (4) nine-item depression subscale of K-SADS-L; and (5) mean CGI improvement scores.


RESULTS
Paroxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score < or = 8, HAM-D depressed mood item, K-SADS-L depressed mood item, and CGI score of 1 or 2. The response to imipramine was not significantly different from placebo for any measure. Neither paroxetine nor imipramine differed significantly from placebo on parent- or self-rating measures. Withdrawal rates for adverse effects were 9.7% and 6.9% for paroxetine and placebo, respectively. Of 31.5% of subjects stopping imipramine therapy because of adverse effects, nearly one third did so because of adverse cardiovascular effects.


CONCLUSIONS
Paroxetine is generally well tolerated and effective for major depression in adolescents.
Keller
M B
MB
Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI 02906, USA.
Ryan
N D
ND
Strober
M
M
Klein
R G
RG
Kutcher
S P
SP
Birmaher
B
B
Hagino
O R
OR
Koplewicz
H
H
Carlson
G A
GA
Clarke
G N
GN
Emslie
G J
GJ
Feinberg
D
D
Geller
B
B
Kusumakar
V
V
Papatheodorou
G
G
Sack
W H
WH
Sweeney
M
M
Wagner
K D
KD
Weller
E B
EB
Winters
N C
NC
Oakes
R
R
McCafferty
J P
JP
D000293:Adolescent; D000704:Analysis of Variance; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use; D003866:Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007099:Imipramine / Q000627:therapeutic use; D016018:Least-Squares Analysis; D008297:Male; D017374:Paroxetine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D000929:Antidepressive Agents, Tricyclic; D007099:Imipramine; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors