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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03446846 | A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder | PHASE2 | COMPLETED | 360 | — | — | Mar 30, 2018 | Dec 13, 2019 | Dec 17, 2020 | 47 | United States, Bulgaria +5 |
The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated, physician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe conditions. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. The test exhibits high inter-rater reliability and its capacity to differentiate between responders and nonresponders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression.
| Arm | Type | Description |
|---|---|---|
| 5.0 mg MIN-117 | EXPERIMENTAL | MIN-117 5.0 mg (consisting of two 2.5 mg capsules) orally daily for 6 weeks |
| 2.5 mg MIN-117 | EXPERIMENTAL | MIN-117 2.5 mg (consisting of one 2.5 mg capsule and one placebo capsule) orally daily for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo (consisting of two placebo capsules) orally daily for 6 weeks |
| Name | Type | Description |
|---|---|---|
| MIN-117 5.0 mg | DRUG | 5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily |
| MIN-117 2.5 mg | DRUG | 2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily |
| Placebo | DRUG | Placebo administered as two Placebo capsules as a single dose once daily |
Inclusion Criteria: * Participants must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff. * Participants must have provided written consent to participate in the study and understand that they are free to withdraw from the stu...