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Postpartum Depression

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

Sponsored by Sage Therapeutics

About this trial

Last updated 3 years ago

Study ID

547-PPD-202 C

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 45 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

What are the Participation Requirements?

Key Inclusion Criteria:

- Participant either 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).

- 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 had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to
dosing).

- Participant was ≤ six months postpartum.

- Participant was amenable to intravenous therapy.

Key Exclusion Criteria:

- Active psychosis.

- Attempted suicide associated with index case of postpartum depression.

- Medical history of bipolar disorder.

Note: Other protocol-defined inclusion/exclusion criteria applied.

View clinical trial results on registries

Clinicaltrials.gov

Locations

Location

Status

For more information, view the full study details:

NCT02942017