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To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression.
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.
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.
Paroxetine is generally well tolerated and effective for major depression in adolescents.
Jamie Horder2013 Oct 30 12:13 p.m. 1 of 1 people found this helpful
This 2001 paper was discussed in a 2010 feature in the British Medical Journal Newman M, 2010
"Study 329, a study of 275 adolescents, was one of three clinical trials conducted by SmithKline Beecham (as GSK was then known) in the mid 1990s.
Study 329’s results showed that paroxetine was no more effective than the placebo according to measurements of eight outcomes specified by Martin Keller, professor of psychiatry at Brown University, when he first drew up the trial.
Two of these were primary outcomes: the change in total Hamilton Rating Scale (HAM-D) score, and the proportion of “responders” at the end of the eight week acute treatment phase (those with a ≥50% reduction in HAM-D, or a HAM-D score ≤8). The drug also showed no significant effect for the initial six secondary outcome measures.
The drug only produced a positive result when four new secondary outcome measures, which were introduced following the initial data analysis, were used instead. Fifteen other new secondary outcome measures failed to throw up positive results.
An internal SmithKline Beecham document discussing these results and those of another trial that had failed to show paroxetine’s effectiveness noted that it would be “commercially unacceptable to include a statement that efficacy had not been demonstrated.”
SmithKline Beecham commissioned medical communications company Scientific Therapeutics Information to produce a manuscript. An employee of Scientific Therapeutics Information, Sally Laden, drew up a first draft.
The manuscript was then sent to JAMA, which rejected it after peer reviewers highlighted methodological and other problems... The paper was rewritten and sent on to JAACAP. The journal’s peer reviewers noted that the results did not “clearly demonstrate efficacy for paroxetine” and asked whether, given that 50% of placebo treated teenagers improved, selective serotonin reuptake inhibitors were “an acceptable first-line treatment.”
JAACAP nevertheless accepted the paper."
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