A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

Supernus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Severe Postpartum Depression

Treatments: Drug: SAGE-547; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02614547

547-PPD-202 A

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.

Enrollment: 21 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 at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
• 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 was less than or equal to (<=) six months postpartum.
• Participant must be amenable to intravenous therapy.

Key Exclusion Criteria:

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

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received infusion rates of placebo matched to SAGE-547.

Treatment:

Drug: Placebo

SAGE-547

Experimental group

Description:

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

Treatment:

Drug: SAGE-547