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MIJ821 Intravenous Injection for Major Depressive Disorder

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
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with suicidal thoughts reduce their symptoms of depression quickly.

Eligible Conditions
  • Major Depressive Disorder With Suicidal Ideation and Intent

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
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
2,855 Previous Clinical Trials
4,197,150 Total Patients Enrolled

Media Library

MIJ821 Intravenous Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04722666 — Phase 2
Major Depressive Disorder 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
Major Depressive Disorder 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
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04722666 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study confined to individuals over 50 years old?

"As stipulated in the entry prerequisites, individuals must be between 18-65 to participate in this clinical trial."

Answered by AI

Are recruiters actively seeking participants for this research study?

"Affirmative. The information available on clinicaltrials.gov attests to this trial's current recruitment process, which commenced on July 20th 2021 and was last amended October 17th 2022. This medical project is looking for 195 participants across 8 locations."

Answered by AI

Is it possible for me to enroll in this experiment?

"This medical trial is seeking to recruit 195 individuals struggling with psychosis and involutional depression aged 18-65. To qualify for the study, candidates must meet these criteria: current suicidal ideation with intent confirmed by M.I.N.I., acute psychiatric hospitalization clinically warranted per physician assessment, MADRS score above 28 at screening before randomization on Day 1, male or female between 18-65 years old, DSM-5 defined MDD without psychotic features according to a clinical evaluation through M.I.N.I.."

Answered by AI

How many Canadian locations are currently running this investigation?

"At present, 8 clinical trial sites are hosting this medical study. These locations include Toronto, Atlanta and Rockville among other cities. For your convenience and to reduce travel costs, it is best that you select the most proximal site to participate in the trial."

Answered by AI

How many participants is the upper limit for this clinical trial?

"Affirmative. On clinicaltrials.gov, there is clear evidence that the trial in question launched on July 20th 2021 and has recently been updated on October 17th 2022. This study necessitates 195 participants from 8 distinct research facilities."

Answered by AI

What potential risks do patients encounter when receiving MIJ821 Intravenous Injection?

"There is existing evidence to confirm the safety of MIJ821 Intravenous Injection, therefore it was allocated a rating of 2. This being said, no efficacy data has been found in relation to this drug yet as it remains within Phase 2 trials."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Georgia
Maryland
Other
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+

Why did patients apply to this trial?

Just have tried various drugs and I don't feel that they are working. All my life antidepressants have not helped in quelling suicidal thoughts or MDD.
PatientReceived 2+ prior treatments
I have tried many drugs, years of therapy, prayer/meditation.nothing gets rid of my suicidal ideation.
PatientReceived 1 prior treatment
I've suffered from MDD for over two decades. I've tried dozens of treatments, but none have brought more than partial relief.
PatientReceived no prior treatments
I have a sickness and it’s like hard to deal with and I think a new type medication could help this for my mental health needs and I hope for the future .
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722666.
~55 spots leftby Apr 2025
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