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MIJ821 Intravenous Injection for Severe depression

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (first infusion) at 24 hours and up to 52 weeks

Summary

This trial tests MIJ821, a new IV medication, to quickly reduce severe depression symptoms in people with major depression who have suicidal thoughts. It works alongside regular antidepressants, and different doses are being tested for effectiveness and safety.

Eligible Conditions
  • Severe depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (first infusion) at 24 hours and up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (first infusion) at 24 hours and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS)
Secondary study objectives
Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI)
Percentage of participants meeting criteria for relapse in the Extension Period
Percentage of participants meeting criteria for sustained response of ≥50% reduction
+5 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: MIJ821(mg/kg) - high doseExperimental Treatment1 Intervention
MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
Group II: MIJ821 (mg/kg) - very low doseExperimental Treatment1 Intervention
MIJ821 (mg/kg) very low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
Group III: MIJ821 (mg/kg) - very high dose/PlaceboExperimental Treatment2 Interventions
MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1/0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
Group IV: MIJ821 (mg/kg) - very high doseExperimental Treatment1 Intervention
MIJ821 (mg/kg) very high dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
Group V: MIJ821 (mg/kg) - low doseExperimental Treatment1 Intervention
MIJ821 (mg/kg) low dose for 40 minutes IV infusion on Day 1, Day 15 and Day 29
Group VI: MIJ821 (mg/kg) - high dose/PlaceboExperimental Treatment2 Interventions
MIJ821 (mg/kg) high dose for 40 minutes IV infusion on Day 1/0.9% sodium chloride for 40 minutes IV infusion on Day 15 and Day 29
Group VII: PlaceboPlacebo Group1 Intervention
40 minutes IV infusion of 0.9% sodium chloride on Day 1, Day 15 and Day 29

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,477 Total Patients Enrolled

Media Library

MIJ821 Intravenous Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04722666 — Phase 2
Severe depression Research Study Groups: MIJ821 (mg/kg) - high dose/Placebo, MIJ821 (mg/kg) - very high dose/Placebo, MIJ821 (mg/kg) - very low dose, MIJ821 (mg/kg) - low dose, MIJ821(mg/kg) - high dose, MIJ821 (mg/kg) - very high dose, Placebo
Severe depression Clinical Trial 2023: MIJ821 Intravenous Injection Highlights & Side Effects. Trial Name: NCT04722666 — Phase 2
MIJ821 Intravenous Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722666 — Phase 2
Severe depression Patient Testimony for trial: Trial Name: NCT04722666 — Phase 2
~46 spots leftby Nov 2025
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