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Psych Congress  

Correlation of HAMD-17 and EPDS Scores in a Phase 3 Trial of Zuranolone: An Oral GABAA Receptor Positive Allosteric Modulator in Postpartum Depression

Authors  

Kristina Deligiannidis, MD-Director/Associate Professor, Psychiatry and Obstetrics & Gynecology, Feinstein Institutes for Medical Research: Northwell Health; Ming-Yi Huang, PhD-Associate Director, HEOR, Sage Therapeutics, Inc.; Ellison Suthoff, BS, MBA-Director, HEOR and Value Demonstration, Sage Therapeutics, Inc.; Brian Werneburg, PhD-Senior Director, Global Medical Affairs, Medical Affairs Strategy, Sage Therapeutics, Inc.; Robert Lasser, MD, MBA-Vice President, Late Development, Medical Science Late, Sage Therapeutics, Inc.; Handan Gunduz-Bruce, MD, MBA-Senior Medical Director, Medical Science, Medical Science Late, Sage Therapeutics, Inc.; Sarah Acaster, MSc-Director, Acaster Lloyd Consulting Ltd.; Moshe Fridman, PhD-AMF Consulting; Abdul Sankoh, PhD-Senior Vice President, Data Science, Sage Therapeutics, Inc.; Sigui Li, MS-Director, Biostatistics, Data Science, Sage Therapeutics, Inc.; Vijayveer Bonthapally, PhD-Senior Director, Global Health and Outcome Research, HEOR, Sage Therapeutics, Inc.; Stephen Kanes, MD, PhD-Chief Medical Officer, Development Management, Sage Therapeutics, Inc.

Sponsor  
Sage Therapeutics, Inc.

Background: PPD is a common medical complication during and after pregnancy. Zuranolone (SAGE-217) is an investigational neuroactive steroid and GABAA receptor positive allosteric modulator. In a Phase 3 trial in PPD (NCT02978326), zuranolone achieved the primary endpoint of depressive symptom reduction at Day 15 versus placebo, assessed by change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression total score (HAMD-17). This post-hoc analysis examined the correlation between clinician- (HAMD-17) and patient-reported Edinburgh Postnatal Depression Scale (EPDS) scores.

Methods: Women (n=151) ages 18-45, ≤6 months postpartum, with PPD and a HAMD-17 ≥26, were randomized 1:1 to zuranolone or placebo for 2-weeks, with 4-weeks follow-up. HAMD-17 CFB at other time points and EPDS CFB throughout the trial were secondary endpoints. Post-hoc analysis of relationships between HAMD-17 and EPDS CFB scores were assessed by Pearson correlations. Adverse events (AEs) were assessed throughout the study.

Results: Zuranolone achieved a significant reduction in HAMD-17 CFB versus placebo starting at Day 3 (-12.5 vs -9.8, p=0.0252), maintained through Day 45 (-19.2 vs -15.1, p=0.0027), and in EPDS CFB at Day 45 (-11.8 vs -8.3, p=0.0005). HAMD-17 and EPDS CFB scores showed significant, moderate correlations at Days 8 through 45 (Pearson‚Äôs r>0.500; p<0.001 for all). Somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, and sedation were the most common (≥5%) AEs in the zuranolone group.

Conclusions: Significant correlations between clinician- and patient-reported scales may facilitate the translation of research findings to clinical care settings and may demonstrate the relevance of clinical trial outcomes for patients.

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