3 ms·

> 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

> 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 ago
  FWIW: the full prescribing information warns about risks of physical dependance and withdrawal symptoms. The drug also ends up in the mother's breast milk at low levels. (See full prescribing info PDF linked in the article.)
- NickM 3y ago
  If it isn’t harmful That’s a big “if” though.
cbhl 3y ago
Apparently 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 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 ago
FWIW: the full prescribing information warns about risks of physical dependance and withdrawal symptoms. The drug also ends up in the mother's breast milk at low levels. (See full prescribing info PDF linked in the article.)
NickM 3y ago
If it isn’t harmful That’s a big “if” though.

cbhl 3y ago

Apparently 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