Abstract

Adults with major depressive disorder may experience mood improvements within days of taking zuranolone (50 mg/day), a study in The American Journal of Psychiatry suggests. Zuranolone is an oral, once‐daily neuroactive steroid that acts on GABAA receptors. “Patients receiving zuranolone 50 mg/day demonstrated significantly greater improvements in depressive symptoms at day 15 compared with those receiving placebo,” wrote Anita H. Clayton, M.D., of the University of Virginia School of Medicine and colleagues. The study “supports the potential role for a 14‐day therapy with oral zuranolone 50 mg/day in adults with MDD [major depressive disorder], with rapid improvements in depressive symptoms observed at the day 3 visit that were sustained through day 42, relatively high response and remission rates, and a favorable safety profile.” The phase 3 trial included patients who were between the ages of 18 and 64 years, had received a diagnosis of MDD (according to Diagnostic and Statistical Manual of Mental Disorders criteria), had been experiencing symptoms of depression for a least four weeks, and had a Hamilton Depression Rating Scale (HAM‐D) score of at least 24 at screening and before they started taking the assigned study medication. A total of 534 patients (266 in the zuranolone group; 268 in the placebo group) were included in the final analysis. The patients in both groups (who were predominantly white and female) had experienced MDD for a mean of approximately 11 years. Compared with patients who took placebo, those who took zuranolone demonstrated a statistically significant improvement in depressive symptoms at day 15. “Numerically greater improvements in depressive symptoms for zuranolone versus placebo were observed by day 3 (least squares mean change from baseline HAM‐D score, −9.8 vs. −6.8), which were sustained at all visits throughout the treatment and follow‐up periods of the study,” Clayton and colleagues wrote.

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