Original Research J Clin Psychiatry December 2023

Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study

JCP 2024;85(1):10.4088/JCP.23m14845

Full Article Read the complete peer-reviewed article in J Clin Psychiatry. Clinical Summary Patients with major depressive disorder often need faster symptom relief than standard antidepressants provide, but clinicians also need to know whether benefit can be safely recaptured if symptoms return. These interim SHORELINE data address a practical question in longitudinal care: how often patients needed repeat 14-day zuranolone courses over 1 year, and what happened to tolerability and symptom response when they did. FAQ What did the SHORELINE study find about the long-term safety of initial and repeat zuranolone treatment courses in major depressive disorder?

Key Takeaways Tolerability appeared dose sensitive: TEAEs leading to dose reduction occurred in 6.1% (44/725) of the 30-mg Cohort versus 18.6% (37/199) of the 50-mg Cohort, and TEAEs leading to study withdrawal occurred in 4.4% (32/725) versus 8.0% (16/199). Clinical Guide How should clinicians determine whether an adult with major depressive disorder who initially responded to zuranolone should receive a repeat treatment course? Clinical Guide How should clinicians administer a 14-day zuranolone course and monitor tolerability in adults with major depressive disorder based on the SHORELINE study procedures?