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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06979544 | A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD | PHASE3 | COMPLETED | 90 | — | — | Jun 16, 2025 | Feb 17, 2026 | Feb 24, 2026 | 18 | United States |
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
| Arm | Type | Description |
|---|---|---|
| LPCN 1154A Tablets | EXPERIMENTAL | LPCN 1154A |
| Placebo Tablets | PLACEBO_COMPARATOR | Placebo Tablets |
| Name | Type | Description |
|---|---|---|
| LPCN 1154A | DRUG | Oral LPCN 1154A tablets for 48 hours |
| Placebo | DRUG | Oral Placebo Tablets for 48 hours |
Key Inclusion Criteria: * Are female between 15 and 45 years of age, inclusive; * Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery * Are \< 12 months postpartum at Screening * Hamilton Depression Rating Scale (HAM-D) 17-item...