C-SSRS (Columbia Suicide Severity Rating Scale)
Psychiatry· appears in 81+ cited findings in this library
What it is and how the reviews use it
The C-SSRS (Columbia Suicide Severity Rating Scale) is an endpoint used in regulatory review documents to assess suicidal ideation and behavior. It serves as a measure to identify and quantify the emergence or presence of suicidal thoughts and actions in subjects during clinical trials. While the definitional facts do not specify its range or severity bands, the scale is used to capture various aspects of suicidality, from a 'wish to be dead' to more severe behaviors.
Regulatory reviews in this library frequently use the C-SSRS to report the incidence or prevalence of suicidal ideation and behavior. For instance, in the review for Rxulti, the emergence of serious suicidal ideation (C-SSRS) was reported in 2 (0.7%) subjects. For Lybalvi, 10.1% of subjects reported suicidal ideation on C-SSRS. The C-SSRS is also used to define exclusion criteria, such as 'Yes to any item within 12 months' for C-SSRS behavior in the Cobenfy review, or to indicate high risk for suicide, with a C-SSRS score of '4 or 5' for Auvelity.
Real examples — cited to the source page
| Rxulti | Emergence of serious suicidal ideation (C-SSRS) | 2 (0.7%) | Otsuka Holdings Co., Ltd. — Rxulti EMA EPAR variation assessment repor, p.20 |
| Cotempla Xr-Odt | Subjects with suicidal ideation or behavior (C-SSRS) | 0 | NEOS THERAPS INC — Cotempla Xr-Odt FDA Review (NDA205489, ORIG 1, 2017, p.43 |
| Erzofri | Suicidal ideation (C-SSRS) | 1 | LUYE INNOMIND PHARMA — Erzofri FDA Review (NDA216352, ORIG 1, 2024), p.96 |
| Lybalvi | Subjects reporting suicidal ideation on C-SSRS | 10.1 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.222 |
| Spravato | Percentage of subjects with lifetime history of suicidal ideation (C-SSRS) | 40 | Johnson & Johnson — Spravato FDA Review (NDA211243, ORIG 1, 2019), p.60 |
| Cobenfy | Exclusion criteria: C-SSRS behavior | Yes to any item within 12 months | Bristol-Myers Squibb Company — Cobenfy FDA Review (NDA216158, ORIG 1,, p.285 |
| Auvelity | C-SSRS score indicating high risk for suicide | 4 or 5 | Axsome Therapeutics, Inc. — Auvelity FDA Review (NDA215430, ORIG 1, 20, p.80 |
| Azstarys | Wish to be dead (C-SSRS item 1) | 1 | COMMAVE SUB — Azstarys FDA Review (NDA212994, ORIG 1, 2021), p.128 |
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.