NCT02942004Phase 3Completed

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

Study sponsor: Supernus Pharmaceuticals, Inc. · SUPN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2017-09-24Actual

Enrollment · participants138Actual

Source updated2025-10-14Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Postpartum Depression

Treatments or interventions studied

PlaceboDrug
SAGE-547 60 μg/kg/hDrug
SAGE-547 90 μg/kg/hDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score; description: The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.; timeFrame: Baseline, Hour 60

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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