A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

Biogen

Status and phase

Completed

Phase 3

Conditions

Postpartum Depression

Treatments

Drug: Placebo

Drug: SAGE 217 30 mg Capsules

Drug: SAGE-217 15/20 mg Oral Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02978326

217-PPD-201

Details and patient eligibility

About

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Full description

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

Enrollment

276 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, must agree to temporarily cease giving breast milk to her infant(s)
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 the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
Participant was <=six months postpartum.

Key Exclusion Criteria:

Active psychosis
Attempted suicide associated with current episode of postpartum depression
Medical history of seizures
Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

276 participants in 3 patient groups, including a placebo group

Part A: SAGE-217 15/20 mg Oral Solution

Experimental group

Description:

Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.

Treatment:

Drug: SAGE-217 15/20 mg Oral Solution

Part B: Placebo

Placebo Comparator group

Description:

Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

Treatment:

Drug: Placebo

Part B: SAGE 217 30 mg Capsules

Experimental group

Description:

Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.