Trial intelligence / Profile preview

SAGE-547 in severe postpartum depression

NCT02285504Phase 2Completed

Sponsor
Supernus Pharmaceuticals, Inc.
Start
Jan 2015
Primary completion
Jun 2015
Modality
Small Molecules
Countries
1
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Overview

Phase 2, open-label, single-arm trial of brexanolone in postpartum depression (PPD), sponsored by Supernus Pharmaceuticals, Inc. Primary endpoints: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), Change From Baseline in Clinical Laboratory Measures (ALT, AST, GGT, CO2, Sodium, Potassium, Chloride, Glucose, Bilirubin, Calcium, BUN, Creatinine, Albumin, Protein, Hemoglobin, Hematocrit,… at Day 4 and 4 more. Started Jan 2015; status: completed.

02

Drugs

brexanolone
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Conditions

postpartum depression (PPD)

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