Zuranolone improves symptoms in adults with major depressive disorder

Treatment with zuranolone 50 mg/day in adults with major depressive disorder (MDD) results in greater improvements in depressive symptoms at day 15, demonstrating a rapid time to effect (day 3), and is generally well tolerated, with no new safety concerns compared with lower dosages, reports a study.

A total of 543 patients (aged 18‒64 years) with severe MDD were randomly assigned to receive either zuranolone 50 mg or placebo once daily for 14 days. The primary endpoint was change from baseline in total score on the 17-item Hamilton Depression Rating Scale (HAM-D) at day 15. The researchers also assessed safety and tolerability by incidence of adverse events (AEs).

Of the participants, 534 (266 in the zuranolone group and 268 in the placebo group) completed the trial. Patients treated with zuranolone achieved significant improvements in depressive symptoms at day 15 (least squares mean [LSM] mean change from baseline HAM-D score, ‒14.1 vs ‒12.3).

Notably, zuranolone elicited numerically greater improvements in depressive symptoms by day 3 as compared with placebo (LSM mean change from baseline HAM-D score, ‒9.8 vs ‒6.8). Such improvements were sustained at all visits throughout the treatment and follow-up periods (through day 42, with the difference remaining nominally significant through 12).

However, serious AEs occurred in two patients in each group. Nine patients in the zuranolone group and four in the placebo group discontinued treatment due to AEs.

“These findings support the potential of zuranolone in treating adults with MDD,” the researchers said.