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CompletedNCT02281773

Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period for schizophrenia

This study is completed in the United States, in Canada, in Germany, .... It is testing Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period for schizophrenia.

SchizophreniaDrugFrom 18 Years to 55 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 BI 409306 100 mg QD may be useful for adults experiencing schizophrenia.

What would participation involve?

Participants may receive BI 409306 100 mg QD, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Canada, in Germany, and in Japan.

Who is it mainly for?

This study appears to be mainly for adults with schizophrenia.

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: November 10, 2014
Recruitment status
Completed
Enrollment listed in the registry
518
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, Canada, Germany, ...
Age range
From 18 Years to 55 Years
Official registry ID
NCT02281773
Official title
A Phase II Randomised, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period in Patients With Schizophrenia on Stable Antipsychotic Treatment

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.

Canada · 2 sites
  • Dr. Alexander McIntyre Inc.
    Penticton, British Columbia
    Site status: Not listed — confirm with the team
  • Depression, Mood Disorders and Schizophrenia Treatment Centr
    Burlington, Ontario
    Site status: Not listed — confirm with the team
Germany · 3 sites
  • Universitätsklinikum Köln (AöR)
    Cologne
    Site status: Not listed — confirm with the team
  • LVR-Klinikum Düsseldorf
    Düsseldorf
    Site status: Not listed — confirm with the team
  • Uniklinikum Heidelberg
    Heidelberg
    Site status: Not listed — confirm with the team
Japan · 10 sites
  • Fujita Health University Hospital
    Aichi, Toyoake
    Site status: Not listed — confirm with the team
  • Hokkaido University Hospital
    Hokkaido, Sapporo
    Site status: Not listed — confirm with the team
  • Kobe University Hospital
    Hyogo, Kobe
    Site status: Not listed — confirm with the team
  • Nara Medical University Hospital
    Nara, Kashihara
    Site status: Not listed — confirm with the team
  • Kansai Med. Univ. Med. Ctr., Osaka, Neuropsychiatry
    Osaka, Moriguchi-city
    Site status: Not listed — confirm with the team
  • Hizen Psychiatric Center, Saga, PSY
    Saga, Kanzaki-gun
    Site status: Not listed — confirm with the team
  • Iwaki Clinic, Tokushima, Psychosomatic Medicine
    Tokushima, Anan
    Site status: Not listed — confirm with the team
  • National Center Neurology and Psychiatry
    Tokyo, Kodaira
    Site status: Not listed — confirm with the team
  • Showa University Karasuyama Hospital
    Tokyo, Setagaya
    Site status: Not listed — confirm with the team
  • Showa University East Hospital
    Tokyo, Shinagawa
    Site status: Not listed — confirm with the team
Taiwan · 4 sites
  • Chang-Hua Christian Hospital
    Changhua
    Site status: Not listed — confirm with the team
  • Kai-Syuan Psychiatric Hospital
    Kaohsiung City
    Site status: Not listed — confirm with the team
  • NCKUH
    Tainan
    Site status: Not listed — confirm with the team
  • Taipei City Hospital
    Taipei
    Site status: Not listed — confirm with the team
United States · 24 sites
  • K and S Professional Research Services, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Comprehensive Clinical Development, Inc.
    Cerritos, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Network
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Pacific Institute of Medical Research
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • SRSD, Inc. dba Synergy San Diego
    National City, California
    Site status: Not listed — confirm with the team
  • NRC Research Institute
    Orange, 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
  • Collaborative Neuroscience Network
    Torrance, California
    Site status: Not listed — confirm with the team
  • Comprehensive Clinical Development
    Washington D.C., District of Columbia
    Site status: Not listed — confirm with the team
  • Innovative Clinical Research
    Lauderhill, Florida
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Behavioral Clinical Research, Inc.
    North Miami, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Center
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Northwestern University
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Uptown Research Institute
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Lake Charles Clinical Trials LLC
    Lake Charles, Louisiana
    Site status: Not listed — confirm with the team
  • Mid-America Clinical Research, LLC
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • St. Louis Clinical Trials
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Neurobehavioral Research, Inc.
    Cedarhurst, New York
    Site status: Not listed — confirm with the team
  • Finger Lakes Research
    Rochester, New York
    Site status: Not listed — confirm with the team
  • University of Rochester Medical Center
    Rochester, New York
    Site status: Not listed — confirm with the team
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • Community Clinical Research, Inc.
    Austin, Texas
    Site status: Not listed — confirm with the team
  • InSite Clinical Research
    DeSoto, Texas
    Site status: Not listed — confirm with the team

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Study ID: NCT02281773. We help you review the study, but cannot decide medical eligibility.
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 schizophrenia. 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 BI 409306 100 mg QD, BI 498306 50 mg QD, Placebo, BI 498306 25 mg QD, BI 409306 10 mg QD. 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 schizophrenia; age range: From 18 Years to 55 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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