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Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.

Overview of attention for article published in British Medical Journal, September 2015
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  • In the top 5% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#31 of 33,326)
  • High Attention Score compared to outputs of the same age (99th percentile)
  • High Attention Score compared to outputs of the same age and source (99th percentile)

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mendeley
173 Mendeley
citeulike
1 CiteULike
Title
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.
Published in
British Medical Journal, September 2015
DOI 10.1136/bmj.h4320
Pubmed ID
Authors

Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude, Le Noury, Joanna, Nardo, John M, Healy, David, Jureidini, Jon, Raven, Melissa, Tufanaru, Catalin, Abi-Jaoude, Elia

Abstract

To reanalyse SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine. Double blind randomised placebo controlled trial. 12 North American academic psychiatry centres, from 20 April 1994 to 15 February 1998. 275 adolescents with major depression of at least eight weeks in duration. Exclusion criteria included a range of comorbid psychiatric and medical disorders and suicidality. Participants were randomised to eight weeks double blind treatment with paroxetine (20-40 mg), imipramine (200-300 mg), or placebo. The prespecified primary efficacy variables were change from baseline to the end of the eight week acute treatment phase in total Hamilton depression scale (HAM-D) score and the proportion of responders (HAM-D score ≤8 or ≥50% reduction in baseline HAM-D) at acute endpoint. Prespecified secondary outcomes were changes from baseline to endpoint in depression items in K-SADS-L, clinical global impression, autonomous functioning checklist, self-perception profile, and sickness impact scale; predictors of response; and number of patients who relapse during the maintenance phase. Adverse experiences were to be compared primarily by using descriptive statistics. No coding dictionary was prespecified. The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group. Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 173 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Germany 2 1%
Brazil 2 1%
United States 2 1%
Spain 1 <1%
Switzerland 1 <1%
France 1 <1%
United Kingdom 1 <1%
Denmark 1 <1%
Belgium 1 <1%
Other 2 1%
Unknown 159 92%

Demographic breakdown

Readers by professional status Count As %
Researcher 29 17%
Student > Bachelor 22 13%
Student > Master 22 13%
Other 19 11%
Student > Ph. D. Student 17 10%
Other 48 28%
Unknown 16 9%
Readers by discipline Count As %
Medicine and Dentistry 81 47%
Psychology 33 19%
Agricultural and Biological Sciences 16 9%
Neuroscience 6 3%
Social Sciences 5 3%
Other 16 9%
Unknown 16 9%

Attention Score in Context

This research output has an Altmetric Attention Score of 1354. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 June 2017.
All research outputs
#776
of 7,924,227 outputs
Outputs from British Medical Journal
#31
of 33,326 outputs
Outputs of similar age
#31
of 218,986 outputs
Outputs of similar age from British Medical Journal
#2
of 905 outputs
Altmetric has tracked 7,924,227 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 99th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 33,326 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 22.6. This one has done particularly well, scoring higher than 99% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 218,986 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 99% of its contemporaries.
We're also able to compare this research output to 905 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 99% of its contemporaries.