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Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

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, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection

Summary

This trial tests a new drug, MIJ821, given as a one-time injection to help people with depression that hasn't improved with usual treatments. Researchers will see if it reduces depression symptoms and check for any side effects.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection 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 MADRS total score 24 hours after injection
Secondary study objectives
Dose-response relationship of MIJ821
Exposure-response relationship of MIJ821
MADRS total scores
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MIJ821 - medium doseExperimental Treatment1 Intervention
Single subcutaneous administration of medium dose of MIJ821 on Day 1
Group II: MIJ821 - low doseExperimental Treatment1 Intervention
Single subcutaneous administration of low dose of MIJ821 on Day 1
Group III: MIJ821 - high doseExperimental Treatment1 Intervention
Single subcutaneous administration of high dose of MIJ821 on Day 1
Group IV: PlaceboPlacebo Group1 Intervention
Single subcutaneous administration of 0.9% sodium chloride on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIJ821 Subcutaneous Injection - medium dose
2023
Completed Phase 2
~60
MIJ821 Subcutaneous Injection - high dose
2023
Completed Phase 2
~60
MIJ821 Subcutaneous Injection - low dose
2023
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,256 Total Patients Enrolled

Media Library

MIJ821 Subcutaneous Injection - high dose Clinical Trial Eligibility Overview. Trial Name: NCT05454410 — Phase 2
Major Depressive Disorder Research Study Groups: MIJ821 - low dose, MIJ821 - medium dose, MIJ821 - high dose, Placebo
Major Depressive Disorder Clinical Trial 2023: MIJ821 Subcutaneous Injection - high dose Highlights & Side Effects. Trial Name: NCT05454410 — Phase 2
MIJ821 Subcutaneous Injection - high dose 2023 Treatment Timeline for Medical Study. Trial Name: NCT05454410 — Phase 2
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05454410 — Phase 2
~20 spots leftby Dec 2025
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