Clinical trial

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression

Name

217-PPD-201

Description

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).

Trial arms

Trial start

2017-01-04

Estimated PCD

2018-11-15

Trial end

2018-12-11

Status

Completed

Phase

Early phase I

Treatment

SAGE-217 15/20 mg Oral Solution

SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).

Arms:

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

Placebo

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

Arms:

Part B: Placebo

SAGE 217 30 mg Capsules

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

Arms:

Part B: SAGE 217 30 mg Capsules

Size

276

Primary endpoint

Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15

Parts A and B: Baseline, Day 15

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 276, 'type': 'ACTUAL'}}

Updated at

2023-12-15

1 organization

3 products

1 indication

Organization

Biogen

Product

Placebo

Indication

Postpartum Depression

Product

SAGE 217

Product

SAGE-217