A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Postpartum Depression

Treatments: Drug: Placebo; Drug: SAGE-547 90 μg/kg/h

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942017

547-PPD-202 C

Details and patient eligibility

About

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s).
• Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
• Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing).
• Participant was ≤ six months postpartum.
• Participant was amenable to intravenous therapy.

Key Exclusion Criteria:

• Active psychosis.
• Attempted suicide associated with index case of postpartum depression.
• Medical history of bipolar disorder.

Note: Other protocol-defined inclusion/exclusion criteria applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.

Treatment:

Drug: Placebo

SAGE-547 90 μg/kg/h

Experimental group

Description:

Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).

Treatment:

Drug: SAGE-547 90 μg/kg/h