For major depressive disorder (Adjunctive) in adultsWell-established safety and tolerability profile1
There was no single adverse reaction leading to
discontinuation that occurred at a rate of >2%1
| Most common TEAEs at 6 weeks (pooled 501/502 pivotal trials)* | ||
|---|---|---|
| CAPLYTA + ADT (n=483) | PLACEBO + ADT (n=481) | |
| Dizziness | 17% | 5% |
| Dry mouth | 13% | 3% |
| Somnolence/ Sedation | 12% | 2% |
| Nausea | 9% | 4% |
| Fatigue | 8% | 2% |
| Diarrhea | 5% | 1% |
Rates of treatment-emergent adverse events decreased over time for most events in the 6-month, open‑label extension2†
Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.
Well-established safety and tolerability seen across aMDD, bipolar I and II depression, and schizophrenia1
*TEAEs occurring in ≥5% of patients and at more than twice the rate of placebo in Studies 501 and 502 (pooled incidence). Serious TEAEs were rare, occurring in 1 patient per group, and not considered related to treatment: CAPLYTA + ADT, polypectomy; ADT alone, joint dislocation.1,2
†Most TEAEs (>98%) were mild to moderate in severity. 46.8% of patients with TEAEs had first onset within the first 4 weeks of open-label CAPLYTA administration.2
AE=adverse event; ADT=antidepressant therapy; aMDD=adjunctive major depressive disorder; MDD=major depressive disorder; TEAE=treatment-emergent adverse event.
