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NCT03756129 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT03756129: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03756129 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03756129, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a weekly or bi-weekly basis. The efficacy was measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration was 6 weeks of treatment plus 1 month of follow up period.
Primary Outcome
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. Highe
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG MIJ821
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2020-03-23 |
| Phase | Phase 2 |
What the finished NCT03756129 record still lists
NCT03756129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03756129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03756129 about?
NCT03756129 is a clinical study titled "Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression". This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a weekly or bi-weekly basis...
What is the current status of trial NCT03756129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2019-02-08. Estimated completion is 2020-03-23.
What interventions are being tested in trial NCT03756129?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), MIJ821 (DRUG).
Who is sponsoring clinical trial NCT03756129?
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 NCT03756129's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 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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