4 ms·
> The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17),
by pessimizer 3y ago
> The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15. Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups.
Why would you mention the number of items on the scale, but not mention the number of points the drug gained? Is it that professionals normally refer to it as the "17-item Hamilton depression rating scale"?
That they're mentioning the number of points in the scale, but not the number of points gained, makes me wonder if this barely limped into significance under the most favorable conditions.
- duskwuff 3y ago> Why would you mention the number of items on the scale, but not mention the number of points the drug gained? Is it that professionals normally refer to it as the "17-item Hamilton depression rating scale"? Correct. "17-item Hamilton depression rating scale" (or HAMD-17) is the precise name of the scale; "17-item" is required to distinguish it from other variations with different numbers of questions. The precise improvement in scoring is undoubtedly present in the clinical trial paper, but isn't relevant to a FDA press release about their approval of the drug. https://dcf.psychiatry.ufl.edu/files/2011/05/HAMILTON-DEPRESSION.pdf https://dcf.psychiatry.ufl.edu/files/2011/05/HAMILTON-DEPRES...
- ellisv 3y ago> The precise improvement in scoring is undoubtedly present in the clinical trial paper, but isn't relevant to a FDA press release about their approval of the drug. Exactly. If it isn’t harmful, it doesn’t have to be very helpful — the effect can be small and significant.
- cbhl 3y agoApparently the brand name `Zurzuvae` in the first paragraph links to a PDF of the full prescribing info from the FDA. Pages 17-18 list the exact changes in HAM-D score over the first 15 days on the drug and the following 30 days after. Both Zurzuvae and Placebo showed improvement in HAM-D over the 15 day period, but Zurzuvae showed a greater improvement. (From 28.6 to 13, vs 28.8 to 17.2, for a difference of -4.0 points, where lower is better.) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/21...
- psychphysic 3y ago> Both Zurzuvae and Placebo showed improvement in HAM-D over the 15 day period Which is why everyone wanted to see it compared to Alprazolam/Xanax or Zopiclone
- ellisv 3y agoLooks like about 4 points. [1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/21...
- xmddmx 3y agoOn the 17 item HAM-D here are the typical score ranges [1] Not depressed: 0–7 Mild (subthreshold): 8–13 Moderate (mild): 14–18 Severe (moderate): 19–22 Very severe (severe): >23 So, a 4 point difference vs placebo is what I would consider a "clinically significant" improvment, e.g. about the difference between mild vs. moderate, or moderate to severe. https://en.wikipedia.org/wiki/Hamilton_Rating_Scale_for_Depression#Levels_of_depression https://en.wikipedia.org/wiki/Hamilton_Rating_Scale_for_Depr...
- Palomides 3y agobased on a look at the actual contents of the HAM-D, four points isn't exactly an impressive improvement for a $11,000 treatment a four point improvement could be a person stops fidgeting during the interview daily reminder that psychology is the worst science in terms of the replication crisis
- NickM 3y agoIf you think that’s bad, go look up some SSRI meta analyses. The average HAM-D improvement vs placebo is only about 2 points.