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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04969510 | A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder | PHASE2 | COMPLETED | 110 | — | — | Jun 24, 2021 | Aug 2, 2022 | Aug 19, 2022 | 24 | United States, Australia |
| NCT04832425 | A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder | PHASE2 | COMPLETED | 216 | — | — | Mar 30, 2021 | May 5, 2022 | Jul 21, 2022 | 31 | United States, Australia |
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
| Arm | Type | Description |
|---|---|---|
| PRAX-114 (10 mg) | EXPERIMENTAL | 10 mg PRAX-114 once daily |
| PRAX-114 (20 mg) | EXPERIMENTAL | 20 mg PRAX-114 once daily |
| PRAX-114 (40 mg) | EXPERIMENTAL | 40 mg PRAX-114 once daily |
| PRAX-114 (60 mg) | EXPERIMENTAL | 60 mg PRAX-114 once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily |
| PRAX-114 | EXPERIMENTAL | 40 mg PRAX-114 once daily |
| Name | Type | Description |
|---|---|---|
| 10 mg PRAX-114 | DRUG | Once daily oral treatment |
| 20 mg PRAX-114 | DRUG | Once daily oral treatment |
| 40 mg PRAX-114 | DRUG | Once daily oral treatment |
| 60 mg PRAX-114 | DRUG | Once daily oral treatment |
| Placebo | DRUG | Once daily oral treatment |
| PRAX-114 | DRUG | 40 mg once daily |
Inclusion Criteria: 1. Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months. 2. HAM-D17 total score of ≥20 at Screening and Baseline 3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive). 4. Adjunctive treatment participants only: Inadequate...