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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07592689 | A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) | PHASE3 | RECRUITING | 165 | — | — | May 10, 2026 | Jun 1, 2028 | May 27, 2026 | 27 | United States |
The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value |
| Arm 2 - 50µg DT120 | SHAM_COMPARATOR | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 3 - 100µg DT120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | A substance that is designed to have no therapeutic value |
| DT120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depres...