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

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Postpartum Depression

Treatments: Drug: SAGE-547 60 μg/kg/h; Drug: Placebo; Drug: SAGE-547 90 μg/kg/h

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942004

547-PPD-202 B

Details and patient eligibility

About

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe 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: 138 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants 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) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
• Participants 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 ≥26 at screening and Day 1 (prior to dosing)
• Participant was ≤6 months postpartum at screening
• Participant was amenable to IV therapy

Key Exclusion Criteria:

• Active psychosis
• Attempted suicide associated with index case of postpartum depression
• Medical history of bipolar disorders, schizophrenia, and/or schizoaffective 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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138 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.

Treatment:

Drug: Placebo

SAGE-547 60 μg/kg/h

Experimental group

Description:

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

Treatment:

Drug: SAGE-547 60 μg/kg/h

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