Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DT120 · 4 trials · 2 indications
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.
The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
| 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) |
| Arm 2 - 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...
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