Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 20 of 31 competitors
MIN-117 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in adult patients with MDD to evaluate its efficacy and safety.
MIN-117 is being developed by Minerva Neurosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NERV. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Major Depressive Disorder.
MIN-117 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied in a completed Phase 2 trial for Major Depressive Disorder, and its safety and efficacy are still being evaluated.
MIN-117 has been studied in one completed Phase 2 clinical trial, identified as NCT03446846. This randomized, double-blind, placebo-controlled study enrolled 360 adult patients with Major Depressive Disorder across multiple countries, including the United States, Bulgaria, Finland, Georgia, Moldova, Poland, and Ukraine.
No, MIN-117 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. The drug has not completed the clinical trials and regulatory review process required for approval, and its safety and efficacy have not been established.