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MIJ821 · 3 trials · 3 indications
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), 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 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
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.
To evaluate the relationship between plasma concentration of MIJ821 and brain receptor occupancy by MIJ821 in healthy participants, by using positron emission tomography (PET) with \[11C\]Me-NB1
| Arm | Type | Description |
|---|---|---|
| MIJ821 1 mg | EXPERIMENTAL | Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1. |
| MIJ821 4 mg | EXPERIMENTAL | Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1. |
| MIJ821 10 mg | EXPERIMENTAL | Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1. |
| 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 |
| Cohort 1 | EXPERIMENTAL | MIJ821, starting dose |
| Cohort 2 | EXPERIMENTAL | MIJ821, dose will be defined based on the results of the previous cohort(s). |
| Cohort 3 | EXPERIMENTAL | MIJ821, dose will be defined based on the results of the previous cohort(s). |
| Cohort 4 | EXPERIMENTAL | MIJ821, dose will be defined based on the results of the previous cohort(s). |
| Cohort 5 | EXPERIMENTAL | MIJ821, dose will be defined based on the results of the previous cohort(s). |
| Name | Type | Description |
|---|---|---|
| MIJ821 Subcutaneous Injection 1 mg | DRUG | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
| MIJ821 Subcutaneous Injection 4 mg | DRUG | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
| MIJ821 Subcutaneous Injection 10 mg | DRUG | MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1. |
| Placebo Subcutaneous Injection | DRUG | 0.9% sodium chloride solution administered as a single SC injection on Day 1. |
| MIJ821 | DRUG | Different dosages and different regimen for MIJ821 |
| Placebo | DRUG | Infusion |
| Ketamine | DRUG | Infusion |
Inclusion Criteria: * Signed informed consent obtained prior to participation in the study * Male and female participants, 18 to 65 years of age (inclusive) at screening * DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE) * MADRS score ≥ 24 * Failure to resp...
MIJ821 is an investigational small molecule being developed by Novartis for psychiatric conditions, specifically major depressive disorder and treatment-resistant depression. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MIJ821 is a small molecule being studied for its effects on depression. Its specific molecular target has not been disclosed in available information, so its precise mechanism of action is not fully characterized in public data.
MIJ821 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in depression.
MIJ821 is in Phase 2 clinical development for treatment-resistant depression. It remains investigational and has not received FDA approval. Clinical trials have been completed, but the drug is still being evaluated for safety and efficacy.
MIJ821 has been studied in several completed trials, including NCT03756129, a Phase 2 proof-of-concept study in 70 patients with treatment-resistant depression, and NCT05454410, a Phase 2 study in 60 participants with the same condition. A Phase 1 PET study (NCT05666687) in healthy volunteers also evaluated brain receptor occupancy.
MIJ821 is a distinct investigational compound developed by Novartis. It is not known to be the same as any other marketed depression medication, and no alternative names have been associated with it in available clinical trial information.