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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03756129 | Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression | PHASE2 | COMPLETED | 70 | — | — | Feb 8, 2019 | Mar 23, 2020 | Oct 8, 2021 | 12 | United States, Spain |
Efficacy. To assess change from baseline in the total MADRS score. The efficacy of MIJ821 in treatment-resistant depression will be compared to the placebo after single dose administration. MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment: the test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
| Arm | Type | Description |
|---|---|---|
| MIJ821 low dose weekly | EXPERIMENTAL | Infusion. MIJ821 low dose weekly - 0.16 mg/kg |
| MIJ821 low dose bi-weekly | EXPERIMENTAL | Infusion. MIJ821 low dose bi-weekly - 0.16 mg/kg |
| MIJ821 high dose weekly | EXPERIMENTAL | Infusion. MIJ821 high dose weekly - 0.32 mg/kg |
| MIJ821 high dose bi-weekly | EXPERIMENTAL | Infusion. MIJ821 high dose bi-weekly - 0.32 mg/kg |
| Placebo weekly | PLACEBO_COMPARATOR | Infusion. Placebo weekly |
| Ketamine 0.5 mg/kg weekly | ACTIVE_COMPARATOR | Infusion. Ketamine 0.5 mg/kg weekly |
| Name | Type | Description |
|---|---|---|
| MIJ821 | DRUG | Different dosages and different regimen for MIJ821 |
| Placebo | DRUG | Infusion |
| Ketamine | DRUG | Infusion |
Key Inclusion Criteria: * Signed informed consent. * Male and female subjects, 18 to 65 years of age (inclusive) at screening. * SCID-based DSM-5 defined major depressive episode at the time of screening * Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 24 at screening and baseline * Fail...