A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Biogen

Status and phase: Completed; Phase 3

Conditions: Depression, Postpartum

Treatments: Drug: Placebo; Drug: SAGE-217

Study type: Interventional

Funder types: Industry

Identifiers

NCT04442503

2020-001424-34 (EudraCT Number)

217-PPD-301

Details and patient eligibility

About

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Full description

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
• Participant has 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 Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
• Participant is ≤12 months postpartum at screening and Day 1.

Exclusion criteria

• Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
• Participant has active psychosis per investigator assessment.
• Participant has a medical history of nonfebrile seizures.
• Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• Participant has a history of sleep apnea.

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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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.

Treatment:

Drug: Placebo

SAGE-217 50 mg

Experimental group

Description:

Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

Treatment:

Drug: SAGE-217