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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07226661 | Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder | PHASE2 | RECRUITING | 230 | — | — | Jan 19, 2026 | Jan 31, 2027 | Mar 24, 2026 | 1 | United States |
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.
| Arm | Type | Description |
|---|---|---|
| SPN-821 2400 mg | EXPERIMENTAL | Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant |
| Placebo | PLACEBO_COMPARATOR | Three oral tablets administered twice a week adjunctive to current antidepressant |
| Name | Type | Description |
|---|---|---|
| SPN-821 2400 mg | DRUG | SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling |
| Placebo | DRUG | Matched placebo oral tablets |
Inclusion Criteria: * Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI * Duration of current MDE of at least 8 weeks * MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit * CGI-S score of ≥ 4 (moderately...