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Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (first infusion) at 24 hours and up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (first infusion) at 24 hours and up to 52 weeks
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 moreTrial 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
2,920 Previous Clinical Trials
4,254,487 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have current thoughts of hurting or killing yourself, as confirmed by a questionnaire given during screening.You can't have taken certain medications called monoamine oxidase inhibitors (MAOIs) for 14 days before screening.You are currently having thoughts of hurting yourself and have confirmed this by answering "Yes" to specific questions on a mental health assessment.You have been diagnosed with autism, dementia, or intellectual disability.You have a history of seizures, except for seizures that occurred in childhood due to fever.You have thoughts of hurting yourself or have acted on those thoughts, but it's not related to depression.You have taken Esketamine or Ketamine within the two months before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: MIJ821 (mg/kg) - high dose/Placebo
- Group 2: MIJ821 (mg/kg) - very high dose/Placebo
- Group 3: MIJ821 (mg/kg) - very low dose
- Group 4: MIJ821 (mg/kg) - low dose
- Group 5: MIJ821(mg/kg) - high dose
- Group 6: MIJ821 (mg/kg) - very high dose
- Group 7: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Severe depression Patient Testimony for trial: Trial Name: NCT04722666 — Phase 2