Phase 2
Completed N=60
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
Source: ClinicalTrials.gov NCT05454410 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection — -14.1; -11.4; -8.4; -8.9 Scores on a Scale
Summary
The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection |
-14.1; -11.4; -8.4; -8.9 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs) |
10; 6; 4; 7; 9; 5 | — |
| SECONDARY Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast) |
231; 89.5; 5.92 | — |
| SECONDARY PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax) |
42.7; 17.5; 2.32 | — |
| SECONDARY PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax) |
0.750; 0.500; 0.500 | — |
| SECONDARY Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits |
-15.3; -9.9; -8.2; -7.4; -14.0; -8.5 | — |
| SECONDARY Dose-response (DR) Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score at 24 Hours After Single SC Injection |
-14.1; -11.4; -8.4; -8.9 | 0.0242 sig |
| SECONDARY Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax |
NA; NA; NA; NA | — |
| SECONDARY Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (Cmax) |
NA | — |
| SECONDARY Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (AUClast) |
NA | — |
| SECONDARY Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter |
NA; NA | — |
Eligibility Criteria
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 respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants
Exclusion Criteria
- Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
- Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
- Participants with current borderline personality disorder or antisocial personality disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability
Data sourced from ClinicalTrials.gov (NCT05454410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.