Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression

Sage Therapeutics

Status and phase: Completed; Phase 2

Conditions: Postpartum Depression

Treatments: Drug: SAGE-547

Study type: Interventional

Funder types: Industry

Identifiers

NCT02285504

547-PPD-201

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

SAGE-547

Experimental group

Description:

Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour \[mcg/kg/hr\] \[4 hrs\], 43 mcg/kg/hr \[4 hrs\] and 64.5 mcg/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \[49 - 52 hrs\], 43 mcg/kg/hr \[53 - 56 hrs\] and 21.5 mcg/kg/hr \[57 - 60 hrs\] on Day 3).

Treatment:

Drug: SAGE-547