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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07284667 | ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response | PHASE2 | RECRUITING | 153 | — | — | Nov 14, 2025 | Sep 1, 2027 | Jun 8, 2026 | 21 | United States |
The MADRS is a clinician-rated tool that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.
| Arm | Type | Description |
|---|---|---|
| ACP-211 600 mg | EXPERIMENTAL | ACP-211 600 mg, administered orally twice weekly |
| ACP-211 300 mg | EXPERIMENTAL | ACP-211 300 mg, administered orally twice weekly |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, administered orally twice weekly |
| Name | Type | Description |
|---|---|---|
| ACP-211 | DRUG | ACP-211 monotherapy |
| Placebo | DRUG | Placebo control |
Inclusion Criteria: * Adults ≥18 and ≤65 years of age * Provides written informed consent * Clinical diagnosis of MDD * History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode * Currently treated with an approved an...