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CompletedNCT06558344

Safety study of 5 mg BI 1569912 in depression

This study is completed in the United States and in Japan. It is testing 5 mg BI 1569912 for 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 5 mg BI 1569912 may be useful for adults experiencing depression.

What would participation involve?

Participants may receive 5 mg BI 1569912, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Japan and in the United States.

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: October 1, 2024
Recruitment status
Completed
Enrollment listed in the registry
225
Sponsor
Boehringer Ingelheim
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
Age range
From 18 Years to 65 Years
Official registry ID
NCT06558344
Official title
A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder

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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 · 6 sites
  • Uematsu Mental Clinic
    Fukuoka, Chikugo
    Site status: Not listed — confirm with the team
  • Kaku Mental Clinic
    Fukuoka, Fukuoka
    Site status: Not listed — confirm with the team
  • Hirota Clinic
    Fukuoka, Kurume
    Site status: Not listed — confirm with the team
  • Yutaka Clinic
    Kanagawa,Sagamihara
    Site status: Not listed — confirm with the team
  • Maynds Tower Mental Clinic
    Tokyo, Shibuya-ku
    Site status: Not listed — confirm with the team
  • Ichigaya Himorogi Clinic
    Tokyo, Shinjuku-ku
    Site status: Not listed — confirm with the team
United States · 35 sites
  • Clinical Innovations, Inc
    Bellflower, California
    Site status: Not listed — confirm with the team
  • ASCLEPES Research Centers, P.C. dba Alliance Research
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Excell Research Inc.
    Oceanside, California
    Site status: Not listed — confirm with the team
  • CiTrials-Riverside-63180
    Riverside, California
    Site status: Not listed — confirm with the team
  • Artemis Institute for Clinical Research, LLC
    San Diego, California
    Site status: Not listed — confirm with the team
  • Lumos Clinical Research
    San Jose, California
    Site status: Not listed — confirm with the team
  • California Neuroscience Research
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • Pacific Clinical Research Management Group LLC
    Upland, California
    Site status: Not listed — confirm with the team
  • Research Centers of America-Hollywood-67537
    Hollywood, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc-Jacksonville-62642
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • CCM Clinical Research Group, LLC-Miami-68482
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Optimus U Corporation-Miami-69452
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc-Orlando-62685
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Advanced Discovery Research LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • iResearch Atlanta
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Psych Atlanta, PC
    Marietta, Georgia
    Site status: Not listed — confirm with the team
  • Pharmasite Research, Incorporated
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Copley Clinical
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Boston Clinical Trials
    Roslindale, Massachusetts
    Site status: Not listed — confirm with the team
  • Adams Clinical
    Watertown, Massachusetts
    Site status: Not listed — confirm with the team
  • Psychiatric Care and Research Center
    O'Fallon, Missouri
    Site status: Not listed — confirm with the team
  • ActivMed
    Portsmouth, New Hampshire
    Site status: Not listed — confirm with the team
  • Center For Emotional Fitness
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • Bio Behavioral Health
    Toms River, New Jersey
    Site status: Not listed — confirm with the team
  • Integrative Clinical Trials LLC
    Brooklyn, New York
    Site status: Not listed — confirm with the team
  • Neurobehavioral Research, Inc.
    Cedarhurst, New York
    Site status: Not listed — confirm with the team
  • Berman Clinical
    New York, New York
    Site status: Not listed — confirm with the team
  • Davis Clinical
    The Bronx, New York
    Site status: Not listed — confirm with the team
  • Sooner Clinical Research, Inc
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Surburban Research Associates, Inc.
    Media, Pennsylvania
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc-Memphis-65988
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • FutureSearch Trials of Dallas, LP
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Grayline Research Center
    Wichita Falls, Texas
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team
  • Core Clinical Research
    Everett, Washington
    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 5 mg BI 1569912, Placebo matching BI 1569912, 10 mg BI 1569912, 20 mg of BI 1569912. 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 Boehringer Ingelheim, 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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