Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder.
In the Phase 3 study, Caplyta reduced depressive symptoms by 4.9 points compared to a placebo on the Montgomery-Asberg Depression Rating Scale (MADRS), a widely used, clinician-rated measure of depression severity. The result was statistically significant and achieved the primary goal of the study.
The drug also showed a significant benefit on a patient-reported measure of depression symptom severity. Dry mouth, fatigue, and tremor were the most commonly reported side effects, and the drug’s overall tolerability profile was consistent with previous studies, the company said.