CGI (Clinical Global Impression)
Psychiatry· appears in 400+ cited findings in this library
What it is and how the reviews use it
CGI (Clinical Global Impression) is an endpoint or rating scale used in clinical trials. The CGI-S (Clinical Global Impression - Severity) score is used to define inclusion criteria for studies, such as a score of 3 for inclusion in an Alkermes plc study for Aristada (Alkermes plc — Aristada FDA Review, p.41). A CGI-S score of ≥4 is often used to indicate moderate or greater severity, as seen in Axsome Therapeutics, Inc.'s Auvelity FDA Review (p.82) and MapLight Therapeutics, Inc.'s ML-007C-MA Phase 2 ADP study (p.11).
Regulatory reviews in this library utilize CGI in various ways. For instance, the mean baseline CGI-S score for the pimavanserin 34 mg QD group was 4.3 in an ACADIA Pharmaceuticals Inc. review for Nuplazid (p.47). For Angelini Pharma's Latuda, the LS mean change in CGI-S score from Baseline to Week 6 for the lurasidone 80 mg/day group was -0.92 (Angelini Pharma — Latuda EMA EPAR variation assessment report, p.42). Additionally, a CGI-S reduction of 1.8 points was reported by Definium Therapeutics, Inc. (p.7).
Real examples — cited to the source page
| Nuplazid | Mean baseline CGI-S score for pimavanserin 34 mg QD group | 4.3 | ACADIA Pharmaceuticals Inc. — Nuplazid FDA Review, p.47 |
| Aristada | CGI-S score for inclusion | 3 | Alkermes plc — Aristada FDA Review, p.41 |
| Auvelity | CGI-S score for moderate or greater severity | ≥4 | Axsome Therapeutics, Inc. — Auvelity FDA Review, p.82 |
| Uzedy | Stability criteria: CGI-S score | ≤4 | Teva Pharmaceutical Industries Limited — Uzedy FDA Review, p.167 |
| Trintellix | CSFQ-14 total score change from Baseline (subgroup CGI-S remitter) | p=0.024 | Takeda Pharmaceutical Company Limited — Trintellix FDA Review, p.81 |
| Qelbree | Study 812P202 CGI-S inclusion criteria | ≥4 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review, p.237 |
| ML-007C-MA | CGI-S score for ML-007C-MA Phase 2 ADP study | ≥4 | MapLight Therapeutics, Inc. — SEC 8-K, p.11 |
| Latuda | LS mean change in CGI-S score from Baseline to Week 6 (lurasidone 80 mg/day group) | -0.92 | Angelini Pharma — Latuda EMA EPAR variation assessment report, p.42 |
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.