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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 developed by Novartis AG for treatment-resistant depression. It is being studied in adults with major depressive disorder that has not responded to prior treatments. MIJ821 is a subcutaneous injection and remains in clinical development rather than being an approved therapy.
MIJ821 is being developed to treat treatment-resistant depression, a form of major depressive disorder that has not improved with standard antidepressant therapies. Clinical studies have enrolled adults with this condition across the United States, Japan, Poland, and Spain. It is investigational and has not been approved for any use.
MIJ821 is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the clinical program evaluating the drug in treatment-resistant depression, including a proof of concept study and a Phase 2 efficacy and safety trial.
MIJ821 is in Phase 2 clinical development. A Phase 2 study of efficacy, safety, tolerability, and pharmacokinetics in treatment-resistant depression has been completed, along with an earlier Phase 2 proof of concept trial. It is investigational and not FDA approved.
MIJ821 has been studied in three completed trials. NCT05454410 was a Phase 2 trial in treatment-resistant depression enrolling 60 participants. NCT03756129 was a Phase 2 proof of concept study enrolling 70 participants. NCT05666687 was a Phase 1 receptor occupancy study in healthy male volunteers in the United Kingdom.