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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02978326 | A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression | PHASE3 | COMPLETED | 276 | — | — | Jan 4, 2017 | Dec 11, 2018 | Dec 15, 2023 | 27 | United States |
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
| Arm | Type | Description |
|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | EXPERIMENTAL | 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. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days. |
| Part B: SAGE 217 30 mg Capsules | EXPERIMENTAL | Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days. |
| Name | Type | Description |
|---|---|---|
| SAGE-217 15/20 mg Oral Solution | DRUG | 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). |
| Placebo | DRUG | SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days. |
| SAGE 217 30 mg Capsules | DRUG | SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days. |
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 thi...