Exhibit 092 ยท Independent reanalysis
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome.
Reanalyzed Study 329 using the original protocol and underlying trial records. Neither paroxetine nor imipramine showed superiority over placebo on the prespecified efficacy variables. Patients with suicidal or self-injurious behaviors on paroxetine (n=93), imipramine (n=95) and placebo (n=87): 5, 3 and 1 in the original publication; 7, 3 and 1 in the sponsor's acute-phase report; 11, 4 and 2 in the reanalysis, which covered the acute and taper phases and included one possible case in each comparator group. The authors acknowledged that different coding and phase assignments change the counts.
- Source
- Le Noury et al., BMJ (Restoring Invisible and Abandoned Trials initiative)
- Date
- September 2015
- Quoted from
- Abstract, Results
- Grade
- Peer-reviewed
- Document
- https://www.bmj.com/content/351/bmj.h4320
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Full published PDF hosted by the authors: https://study329.org/wp-content/uploads/2015/09/Study-329-Final.pdf (safety counts at Table 6, p. 10).