> 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.
> 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.
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.)
> 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.
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.)
On 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.
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.