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CompletedNCT05454410

Single Subcutaneous MIJ821 Injection for treatment-resistant depression

This study is completed in the United States, in Japan, in Poland, .... It is testing Single Subcutaneous MIJ821 Injection for treatment-resistant depression.

DepressionDrugFrom 18 Years to 65 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether MIJ821 Subcutaneous Injection 1 mg may be useful for adults experiencing depression.

What would participation involve?

Participants may receive MIJ821 Subcutaneous Injection 1 mg, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Japan, in Poland, and in Spain.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: March 13, 2023
Recruitment status
Completed
Enrollment listed in the registry
60
Sponsor
Novartis Pharmaceuticals
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Japan, Poland, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT05454410
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Japan · 3 sites
  • Novartis Investigative Site
    Yokohama, Kanagawa
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Kodaira, Tokyo
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Mitaka, Tokyo
    Site status: Not listed — confirm with the team
Poland · 3 sites
  • Novartis Investigative Site
    Bialystok
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Gdansk
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Swiecie North West
    Site status: Not listed — confirm with the team
Spain · 7 sites
  • Novartis Investigative Site
    Seville, Andalusia
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Sabadell, Barcelona
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Sant Boi de Llobregat, Barcelona
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Barcelona, Catalonia
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Pamplona, Navarre
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Barcelona
    Site status: Not listed — confirm with the team
  • Novartis Investigative Site
    Barcelona
    Site status: Not listed — confirm with the team
United States · 3 sites
  • 25Uni of Alabama at Birmingham
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • Research Centers of America LLC
    Oakland Park, Florida
    Site status: Not listed — confirm with the team
  • Interventional Psychiatry Tampa Bay
    Tampa, Florida
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg, MIJ821 Subcutaneous Injection 10 mg, Placebo Subcutaneous Injection. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with depression; age range: From 18 Years to 65 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Novartis Pharmaceuticals, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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