MADRS (Montgomery-Asberg Depression Rating Scale)
Psychiatry· appears in 400+ cited findings in this library
What it is and how the reviews use it
The Montgomery-Asberg Depression Rating Scale (MADRS) is an endpoint used in regulatory review documents to assess the severity of depression. It is frequently used to measure the change from baseline in depressive symptoms. For example, in studies for Symbyax in Treatment-Resistant Depression (TRD), the MADRS LS Mean Change From Baseline (CFB) at Primary Endpoint ranged from -8.6 to -14, as noted in the Johnson & Johnson — Spravato FDA Review (NDA211243, ORIG 1, 2019, p.189). Similarly, for Fluoxetine in TRD, the MADRS LS Mean CFB at Primary Endpoint ranged from -1.2 to -11, and for Vilazodone in MDD, it ranged from -9.7 to -13, according to the same source.
Regulatory reviews in this library utilize MADRS to evaluate treatment efficacy. For instance, Definium Therapeutics, Inc. reported a MADRS change from baseline (DT120 ODT) of -13.6 points. Johnson & Johnson's Spravato FDA Review noted that the percentage of subjects achieving MADRS response (placebo arm) was 3.5%. Additionally, H. Lundbeck A/S's Brintellix EMA EPAR public assessment report showed a MADRS total score change from baseline vs placebo (LS mean difference) of -4.1 points.
Real examples — cited to the source page
| DT120 ODT | MADRS change from baseline | -13.6 | Definium Therapeutics, Inc. — SEC 8-K, p.7 |
| Vraylar | MADRS total score change from baseline (LS Mean Difference) | -0.9 | AbbVie Inc. — Vraylar FDA Review, p.50 |
| Spravato | Percentage of subjects achieving MADRS response (placebo arm) | 3.5 | Johnson & Johnson — Spravato FDA Review, p.79 |
| Auvelity | MADRS total score reduction for responders | ≥50% | Axsome Therapeutics, Inc. — Auvelity FDA Review, p.96 |
| Caplyta | MADRS total score change from baseline (LS Mean Difference vs placebo) | -1.5 | Johnson & Johnson — Caplyta FDA Review, p.120 |
| Trintellix | MADRS change from baseline | -2.2 | Takeda Pharmaceutical Company Limited — Trintellix FDA Review, p.30 |
| Brintellix | MADRS total score change from baseline vs placebo (LS mean difference) | -4.1 | H. Lundbeck A/S — Brintellix EMA EPAR public assessment report, p.155 |
| Zurzuvae | MADRS responder rate (placebo) | 37.1 | Biogen Inc. — Zurzuvae EMA EPAR public assessment report, p.89 |
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.