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MIJ821 - low dose 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, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection
Awards & highlights
Study Summary
This trial will test a single injection as an additional treatment for those with depression that haven't responded to medication.
Eligible Conditions
- Major Depressive Disorder
Timeline
Screening ~ 3 weeks3 visits
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
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
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 MADRS total score 24 hours after injection
Secondary outcome measures
Dose-response relationship of MIJ821
Exposure-response relationship of MIJ821
MADRS total scores
+4 moreTrial 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
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,331 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried two different antidepressant medications, but they did not work for you.You have been diagnosed with or currently have conditions like severe depression with hallucinations, bipolar disorder, schizophrenia, or schizoaffective disorder.You have been diagnosed with major depressive disorder (MDD) and are currently experiencing a major depressive episode (MDE).You currently have borderline personality disorder or antisocial personality disorder.
Research Study Groups:
This trial has the following groups:- Group 1: MIJ821 - low dose
- Group 2: MIJ821 - medium dose
- Group 3: MIJ821 - high dose
- Group 4: 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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05454410 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it hazardous to utilize MIJ821 at a diminished dose?
"Our team at Power approximated MIJ821 - low dose's safety as a 2 because this is a Phase 2 trial, meaning that there are some records of the drug being safe but none exhibiting efficacy."
Answered by AI
Is this research endeavor offering an opportunity for volunteers now?
"Per the information found on clinicaltrials.gov, this trial is still actively looking for participants. The study was launched in late January 2021 and its parameters were most recently revised in early May of that same year."
Answered by AI
What type of volunteers are most suitable for this research project?
"This clinical trial is seeking 56 applicants with a major depressive disorder, aged from 18 to 65."
Answered by AI
Are participants younger than 35 years old eligible for this trial?
"Data from this trial stipulates that the accepted range of ages for participants is 18 to 65. There are a total of 185 trials with patients below 18 and 946 studies that involve people above the age of 65."
Answered by AI
How many subjects are eligible to participate in this trial?
"Affirmative. According to the data hosted on clinicaltrials.gov, the search for patients is ongoing and began on January 31st 2023. The trial was refreshed as recently as 5th of January 2023 and requires 56 volunteers from two different locations."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Pennsylvania
Arizona
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
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’ve had TRD since I was 8 years old. I’ve tried almost every antidepressant on the market. The only med that helped was Abilify added to lexapro but that caused me to have TD. I just want quality of life that I’ve never had in 55 years. I want to wake up without the depression knot in my stomach.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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