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MIN-117 · 1 trial · 1 indication
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...
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MIN-117 is an investigational small molecule being developed for the treatment of major depressive disorder. It has been studied in a Phase 2 clinical trial in adult patients with major depressive disorder. Minerva Neurosciences, Inc. is the developer. MIN-117 is not approved for any indication and remains in clinical development.
MIN-117 is being developed by Minerva Neurosciences, Inc., which trades under the ticker NERV. The company sponsored the Phase 2 clinical trial of MIN-117 in major depressive disorder. Minerva Neurosciences is the sole developer named for this asset.
MIN-117 is in Phase 2 development. The completed Phase 2 trial, NCT03446846, evaluated the efficacy and safety of MIN-117 in adult patients with major depressive disorder. The trial enrolled 360 patients and was randomized, double-blind, and placebo-controlled. MIN-117 is investigational and has not been approved by the FDA.
MIN-117 has been studied in one clinical trial: NCT03446846, titled A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder. This Phase 2 trial is completed and enrolled 360 patients across the United States, Bulgaria, Finland, Georgia, Moldova, Poland, and Ukraine. No active trials are ongoing.