Abstract
Objective: To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression. Method: 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 ≤8 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 ≤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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 762-772 |
| Number of pages | 11 |
| Journal | Journal of the American Academy of Child and Adolescent Psychiatry |
| Volume | 40 |
| Issue number | 7 |
| State | Published - 2001 |
| Externally published | Yes |
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Keywords
- Adolescent
- Imipramine
- Major depression
- Paroxetine
ASJC Scopus subject areas
- Psychiatry and Mental health
- Developmental and Educational Psychology
Cite this
Efficacy of paroxetine in the treatment of adolescent major depression : A randomized, controlled trial. / Keller, Martin B.; Ryan, Neal D.; Strober, Michael; Klein, Rachel G.; Kutcher, Stan P.; Birmaher, Boris; Hagino, Owen R.; Koplewicz, Harold; Carlson, Gabrielle A.; Clarke, Gregory N.; Emslie, Grahm J.; Feinberg, David; Geller, Barbara; Kusumakar, Vivek; Papatheodorou, George; Sack, William H.; Sweeney, Michael; Wagner, Karen; Weller, Elizabeth B.; Winters, Nancy C.; Oakes, Rosemary; McCafferty, James P.
In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 40, No. 7, 2001, p. 762-772.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy of paroxetine in the treatment of adolescent major depression
T2 - A randomized, controlled trial
AU - Keller, Martin B.
AU - Ryan, Neal D.
AU - Strober, Michael
AU - Klein, Rachel G.
AU - Kutcher, Stan P.
AU - Birmaher, Boris
AU - Hagino, Owen R.
AU - Koplewicz, Harold
AU - Carlson, Gabrielle A.
AU - Clarke, Gregory N.
AU - Emslie, Grahm J.
AU - Feinberg, David
AU - Geller, Barbara
AU - Kusumakar, Vivek
AU - Papatheodorou, George
AU - Sack, William H.
AU - Sweeney, Michael
AU - Wagner, Karen
AU - Weller, Elizabeth B.
AU - Winters, Nancy C.
AU - Oakes, Rosemary
AU - McCafferty, James P.
PY - 2001
Y1 - 2001
N2 - Objective: To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression. Method: 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 ≤8 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 ≤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.
AB - Objective: To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression. Method: 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 ≤8 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 ≤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.
KW - Adolescent
KW - Imipramine
KW - Major depression
KW - Paroxetine
UR - http://www.scopus.com/inward/record.url?scp=0034961468&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034961468&partnerID=8YFLogxK
M3 - Article
VL - 40
SP - 762
EP - 772
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 - 7
ER -