Phase 2
N=4
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT02285504 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 4; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAGE-547 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
4; 0 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) |
-3.0; -3.7; 2.7; -0.5; 1.0; 4.7 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride |
-0.5; -2.0; -3.0; -0.5; -1.3; 1.3 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine |
16.0; 28.3; 17.7; -0.05; -0.23; -0.13 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin |
-0.40; -0.33; 0.20; -0.63; -0.43; 0.20 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Hematocrit |
0.15; -1.07; 1.20 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes |
-18.8; -23.3; -4.3; -0.93; -0.03; -1.07 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC) |
-0.030; -0.090; 0.113 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV) |
0.85; -0.53; 0.33 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH) |
-0.3; 0.5; -0.3 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR) |
-0.30; -1.05; -0.37 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH) |
-0.17; 0.33; 1.00 | — |
| PRIMARY Change From Baseline in Clinical Laboratory Measure: Specific Gravity |
-0.0080; -0.0017; -0.0015 | — |
| PRIMARY Change From Baseline in Vital Sign: Blood Pressure |
-2.8; 2.3; -1.0; -5.0; 12.3; 5.0 | — |
| PRIMARY Change From Baseline in Vital Sign: Heart Rate |
-2.5; 5.3; -2.3; -1.5; -3.0; -5.8 | — |
| PRIMARY Change From Baseline in Vital Sign: Body Temperature |
-0.20; 0.15; -0.15; -0.05; 0.03; -0.30 | — |
| PRIMARY Change From Baseline in Vital Sign: Respiratory Rate |
0.0; 0.0; 0.0; 0.0; 0.3; -1.0 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration |
-28.5; -1.0; 13.3; -3.5 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate |
14.3 | — |
| PRIMARY Number of Participants With Physical Examination Findings |
4 | — |
| PRIMARY Number of Participants With Concomitant Medication Usage |
3 | — |
| PRIMARY Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) |
3; 0; 1; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of SAGE-547 |
97.2 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of SAGE-547 |
42 | — |
| SECONDARY Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547 |
3380 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547 |
3160 | — |
| SECONDARY Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547 |
1590 | — |
| SECONDARY Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547 |
66.1 | — |
| SECONDARY Plasma Clearance (CL) of SAGE-547 |
1.08 | — |
| SECONDARY Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score |
-21.8; -23.3; -24.8; -24.3; -24.8; -21.3 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score |
1.8; 1.3; 1.0; 1.3; 1.3; 1.5 | — |
Summary
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
Eligibility Criteria
Inclusion Criteria
- Adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery
- Participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry
Exclusion Criteria
- Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders
- Active psychosis
- Medical history of seizures
Data sourced from ClinicalTrials.gov (NCT02285504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.