Re: Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
I am grateful for the provision of the raw data for the paper “Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence” in the Appendix 2 and the spreadsheets on Study329.org. If one sticks to the MedDRA primary system organ class (SOC) one obtains different results for the adverse events from those presented in Table 5 of the paper.
For example, psychiatric adverse events decrease (from 103 to 57 in the paroxetine group, from 63 to 37 in the imipramine group and from 24 to 13 in the placebo group, see Table below), largely because of the reclassification of akathisia and somnolence into nervous system disorders. Conversely, the nervous systems disorders increase (from 101 to 160 in the paroxetine group, from 114 to 178 in the imipramine group and from 77 to 91 in the placebo group). Although, looking at the verbatim terms in the spreadsheet, it is understandable why the authors classified akathisia as “psychiatric” the case is less clear for somnolence. In general, I would be interested in the authors’ comment on the scope for interpretation left open by their approach.
Competing interests: I have previously co-authored papers with two of the authors of this article (Dr Le Noury and Prof Healy).