HAM-D (Hamilton Depression Rating Scale)
Psychiatry· appears in 207+ cited findings in this library
What it is and how the reviews use it
The Hamilton Depression Rating Scale (HAM-D) is an endpoint used in regulatory reviews to assess depression. The HAMD-17 version has a highest possible total score of 53, as noted in the Axsome Therapeutics, Inc. — Auvelity FDA Review. A HAMD-17 score of 0 to 7 indicates an absence of depression or clinical remission, while a score of 20 or higher signifies at least moderate depression, according to the same review. Minimum HAMD-17 scores for inclusion in studies have been reported as 22 (AbbVie Inc. — Vraylar FDA Review) and 20 (AbbVie Inc. — Vraylar FDA Review).
Regulatory reviews frequently utilize HAM-D to evaluate treatment efficacy. For instance, the Biogen Inc. — Zurzuvae EMA EPAR public assessment report shows a HAMD-17 remission rate of 26.9%. Takeda Pharmaceutical Company Limited's Trintellix FDA Review reported a HAMD-24 change from baseline of -3.3. In the Otsuka Holdings Co., Ltd. — Rexulti FDA Review, the remission rate in the STAR*D trial (HAM-D17 score ≤ 7) was 28%.
Real examples — cited to the source page
| Biogen Inc. — Zurzuvae | HAMD-17 remission rate | 26.9 | Zurzuvae EMA EPAR, p.97 |
| Takeda Pharmaceutical Company Limited — Trintellix | HAMD-24 change from baseline | -3.3 | Trintellix FDA Review, p.30 |
| Otsuka Holdings Co., Ltd. — Rexulti | Remission rate in STAR*D trial (HAM-D17 score ≤ 7) | 28% | Rexulti FDA Review, p.19 |
| Johnson & Johnson — Spravato | HAM-D responder data (VNS) | 30% response in 1 year versus 13% treatment as usual | Spravato FDA Review, p.26 |
| Lipocine Inc. | Placebo-Adjusted HAM-D17 Score Difference (History of Psychiatric Conditions Subset) | -6.1 | SEC 8-K, p.2 |
| AbbVie Inc. — Vraylar | Minimum HAMD-17 score for inclusion | 22 | Vraylar FDA Review, p.110 |
| Axsome Therapeutics, Inc. — Auvelity | HAMD-17 highest possible total score | 53 | Auvelity FDA Review, p.79 |
| FABRE KRAMER — Exxua | HAMD-17 total score for remission in Study 28709 | ≤8 | Exxua FDA Review, p.71 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.