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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06235905 | Open-Label of SPN-820 in Adults With Major Depressive Disorder | PHASE2 | COMPLETED | 40 | — | — | Feb 15, 2024 | Aug 18, 2024 | Oct 21, 2025 | 1 | United States |
The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.
| Arm | Type | Description |
|---|---|---|
| SPN-820 6 x 400 mg capsules | OTHER | - |
| Name | Type | Description |
|---|---|---|
| NV-5138 | DRUG | NV-5138 is a novel, orally bioavailable, mechanistic target of rapamycin complex 1 (mTORC1) signaling enhancer |
Inclusion Criteria: * Male or female subject, aged 18 to 65 years (inclusive) at screening. * Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the M...