Major depressive disorder
Psychiatry· 9 reviewed drugs· 11522 cited findings behind them
What the regulatory reviews cover
This library contains regulatory review documents for several drugs indicated for Major Depressive Disorder (MDD). These include Spravato, Rexulti, Vraylar, Brintellix, Auvelity, Exxua, and Trintellix. The documents detail various efficacy and safety outcomes from clinical trials.
For example, Spravato showed a MADRS total score change from baseline (LS mean treatment difference) for esketamine + SOC vs placebo + SOC of -3.8. Rexulti demonstrated a CMAI Total Score change from baseline at Week 12 (LS mean difference vs placebo) of -2.34. Auvelity reported a MADRS total score change from baseline (LS mean difference vs placebo) of 3.87, while Exxua showed a relapse rate (Applicant's analysis) vs Placebo of 23.0% vs 34.7%. It is important to note that these figures are derived from different studies and are not directly comparable head-to-head.
The drugs — one cited result each
| Spravato Johnson & Johnson | MADRS total score change from baseline (LS mean treatment difference) for esketamine + SOC vs placebo + SOC: -3.8 Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.62 |
| Rxulti Otsuka Holdings Co., Ltd. | 2326 cited findings on the drug page → |
| Rexulti Otsuka Holdings Co., Ltd. | CMAI Total Score change from baseline at Week 12 (LS mean difference vs placebo): -2.34 Rexulti FDA Review (NDA205422, S, p.96 |
| Vraylar AbbVie Inc. | MADRS placebo-subtracted change: -1 to -2.5 AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 9, 2022), p.69 |
| Brintellix H. Lundbeck A/S | MADRS total score change from baseline (meta-analysis): -4.6 H. Lundbeck A/S — Brintellix EMA EPAR public assessment repo, p.101 |
| Auvelity Axsome Therapeutics, Inc. | MADRS total score change from baseline (LS mean difference vs placebo): 3.87 Axsome Therapeutics, Inc. — Auvelity FDA Review (NDA215430,, p.116 |
| Exxua FABRE KRAMER | Relapse rate (Applicant's analysis) vs Placebo: 23.0% vs 34.7% FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.74 |
| Trintellix Takeda Pharmaceutical Company Limited | CSFQ-14 total score change from Baseline (LS mean difference vs escitalopram) at Week 8: 2.2 points Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.79 |
| Trintellix (vortioxetine) Tablets Takeda Pharmaceutical Company Limited | MADRS change from baseline: -7.1 Takeda Pharmaceutical Company Limited — Trintellix FDA Revie, p.30 |
Different drugs were studied in different trials — these figures are not head-to-head comparisons.
Explore the full evidence
Every finding behind these drugs — searchable, comparable and answerable in plain language — is in the Psychiatry research library →
Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only — not medical or investment advice.