Positive Phase 3 Clinical Trial Results: Investigational Postpartum Depression Pill Shows Rapid and Significant Improvement in Depressive Symptoms

Thursday, July 27, 2023

The Feinstein Institutes for Medical Research at Northwell Health have announced the outcomes of the SKYLARK Study, a phase 3 clinical trial investigating an investigational oral neuroactive steroid zuranolone (50mg) pill for postpartum depression (PPD) treatment. The trial showcased rapid and meaningful improvements in depressive symptoms, which could potentially lead to FDA approval as the first oral, at-home, neuroactive steroid therapy for PPD.

Led by Dr. Kristina M. Deligiannidis, the trial revealed statistically significant improvement in depressive symptoms compared to the placebo group. Notably, improvements were observed as early as day 3 (after two doses), with sustained benefits up to day 45. At day 15, 57 percent of women receiving zuranolone experienced a 50 percent or more improvement in depressive symptoms, increasing to 61.9 percent at day 45.

The most common treatment-emergent adverse events reported were somnolence, dizziness, sedation, headache, diarrhea, nausea, urinary tract infection, and COVID-19.

PPD affects approximately one in eight women, and current treatment options may take a considerable amount of time to show relief, if any. The positive results from the SKYLARK Study offer hope for a faster and more effective therapy to address this condition.

Dr. Deligiannidis, the principal investigator of the trial, emphasized the significance of the research in recognizing and treating PPD effectively. The study involved 200 enrolled patients, including diverse participants from various international clinical sites.

The SKYLARK Study builds on the success of previous clinical trials, which demonstrated the improvement of depressive symptoms with zuranolone in PPD patients while being generally well tolerated.

PPD is believed to be influenced by disruptions in the nervous system's stress response, GABA signaling, and neuroactive steroids. The SKYLARK and ROBIN clinical trials have provided substantial evidence for improving depressive symptoms in women with PPD.

Dr. Deligiannidis and the Feinstein Institutes continue to lead groundbreaking research in diagnosing and treating perinatal depression, receiving grants to study brain imaging and develop novel treatments for major depressive disorders.

The positive results from the phase 3 clinical trial mark significant progress in postpartum depression medical research, offering hope for improved treatments in the future.


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