Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02942004 | A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) | PHASE3 | COMPLETED | 138 | — | — | Aug 1, 2016 | Oct 19, 2017 | Oct 14, 2025 | 32 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group. |
| SAGE-547 60 μg/kg/h | EXPERIMENTAL | Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours). |
| SAGE-547 90 μg/kg/h | EXPERIMENTAL | Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h. |
| SAGE-547 60 μg/kg/h | DRUG | Intravenous infusion of SAGE-547. |
| SAGE-547 90 μg/kg/h | DRUG | Intravenous infusion of SAGE-547. |
Key Inclusion Criteria: * Participants 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) from just prior to receiving study drug through nine days (Day 12) after the end of the infu...