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NCT05454410 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT05454410: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT05454410 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05454410, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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)
Primary Outcome
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,
Interventions
- DRUG MIJ821 Subcutaneous Injection 1 mg
- DRUG MIJ821 Subcutaneous Injection 4 mg
- DRUG MIJ821 Subcutaneous Injection 10 mg
- DRUG Placebo Subcutaneous Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2023-11-28 |
| Phase | Phase 2 |
What the finished NCT05454410 record still lists
NCT05454410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which MIJ821 Subcutaneous Injection 1 mg is the first listed.
NCT05454410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05454410 about?
NCT05454410 is a clinical study titled "Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)". 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)
What is the current status of trial NCT05454410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-03-13. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT05454410?
The interventions under investigation include: MIJ821 Subcutaneous Injection 1 mg (DRUG), MIJ821 Subcutaneous Injection 4 mg (DRUG), MIJ821 Subcutaneous Injection 10 mg (DRUG), Placebo Subcutaneous Injection (DRUG).
Who is sponsoring clinical trial NCT05454410?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05454410's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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