Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAGE-217 15 · 1 trial · 1 indication
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...
SAGE-217 15 is being developed for the treatment of postpartum depression, a serious mood disorder that can occur after childbirth. It is an oral small molecule therapy studied in adult women with severe postpartum depression. The drug is investigational and has not been approved for commercial use.
SAGE-217 15 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker symbol BIIB. Biogen is the sponsor of the clinical program evaluating this oral small molecule for postpartum depression.
SAGE-217 15 is in Phase 3 clinical development for postpartum depression. One Phase 3 trial has been completed, and no trials are currently active. The drug remains investigational and has not received FDA approval.
SAGE-217 15 has been evaluated in one completed Phase 3 trial, NCT02978326, titled A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression. The trial enrolled 276 participants across sites in the United States and was randomized, double-blind, and placebo-controlled.