Zuranolone intake improves symptoms among patients with depression

In patients with major depressive disorder, zuranolone at 50 mg/day caused a significant improvement with a short time to effect, says an article published in the American Journal of Psychiatry. 

Anita Clayton and colleagues conducted a study in which they evaluated the effectiveness and safety of a 14-day course of once-daily zuranolone 50 mg, an investigational oral positive allosteric modulator of the gama-aminobutyric acid type A (GABAA) receptor, for the treatment of major depressive disorder.

In this randomised, double-blind, placebo-controlled experiment, patients with severe major depressive disorder between the ages of 18 and 64 were included. For 14 days, patients self-administered 50 mg of zuranolone or a placebo. The 17-item Hamilton Depression Rating Scale (HAM-D) total score change from baseline at day 15 was the primary objective. The frequency of adverse events was used to evaluate safety and tolerability.

The key findings of this study were:

1. The full analysis set consisted of 534 participants out of the 543 randomised patients (266 in the zuranolone group and 268 in the placebo group). 

2. At day 15, patients in the zuranolone group showed a statistically significant reduction in depression symptoms when compared to those in the placebo group. 

3. By day 3, there were numerically greater reductions in depressive symptoms for zuranolone compared to placebo (least squares mean change from baseline HAM-D score, 9.8 vs. 6.8). 

4. These improvements persisted through day 42, with the difference remaining nominally significant through day 12. 

5. Serious side effects occurred in two individuals in each group, and nine patients in the zuranolone group and four in the placebo group stopped taking their medications as a result.

In comparison to previously examined lower dosages, zarianolone was generally well tolerated, with no new safety findings. These results back up zuranolone's potential for treating people with major depressive illness.

Reference: 

Clayton, A. H., Lasser, R., Parikh, S. V., Iosifescu, D. V., Jung, J., Kotecha, M., Forrestal, F., Jonas, J., Kanes, S. J., & Doherty, J. (2023). Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo‐Controlled Phase 3 Trial. In American Journal of Psychiatry. American Psychiatric Association Publishing. https://doi.org/10.1176/appi.ajp.20220459