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TerminatedNCT03230097

Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period for Psychotic Disorders

This study was terminated in the United States, in Canada, in the United Kingdom, .... It is testing Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period for Psychotic Disorders.

SchizophreniaBehavioralFrom 16 Years to 30 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.

Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether BI 409306 may be useful for people experiencing schizophrenia.

What would participation involve?

Participants may receive BI 409306, 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 China, and in the United Kingdom.

Who is it mainly for?

This study appears to be mainly for people 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: September 29, 2017
Recruitment status
Terminated
Enrollment listed in the registry
50
Sponsor
Boehringer Ingelheim
Sponsor type
Unknown or unclear
Study type
Behavioral
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Canada, United Kingdom, ...
Age range
From 16 Years to 30 Years
Official registry ID
NCT03230097
Official title
A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.

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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.

Canada · 4 sites
  • University of Calgary
    Calgary, Alberta
    Site status: Not listed — confirm with the team
  • University of Alberta Hospital (University of Alberta)
    Edmonton, Alberta
    Site status: Not listed — confirm with the team
  • Chatham-Kent Clinical Trials Research Centre
    Chatham, Ontario
    Site status: Not listed — confirm with the team
  • Alan D. Lowe Medicine Professional Corporation
    Toronto, Ontario
    Site status: Not listed — confirm with the team
China · 2 sites
  • Peking University Sixth Hospital
    Beijing
    Site status: Not listed — confirm with the team
  • Shanghai Mental Health Center
    Shanghai
    Site status: Not listed — confirm with the team
United Kingdom · 4 sites
  • Holywell Hospital
    Antrim
    Site status: Not listed — confirm with the team
  • The Barberry National Centre for Mental Health
    Birmingham
    Site status: Not listed — confirm with the team
  • King's College Hospital
    London
    Site status: Not listed — confirm with the team
  • University of Manchester
    Manchester
    Site status: Not listed — confirm with the team
United States · 23 sites
  • ProScience Research Group
    Culver City, California
    Site status: Not listed — confirm with the team
  • University of California San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • PRIME Clinic
    New Haven, Connecticut
    Site status: Not listed — confirm with the team
  • University of Florida College of Medicine
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Medical Research Group of Central Florida
    Orange City, Florida
    Site status: Not listed — confirm with the team
  • Augusta University
    Augusta, Georgia
    Site status: Not listed — confirm with the team
  • Boston Medical Center
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Michigan Clinical Research Institute PC
    Ann Arbor, Michigan
    Site status: Not listed — confirm with the team
  • University of Michigan Health System
    Ann Arbor, Michigan
    Site status: Not listed — confirm with the team
  • Cherry Health
    Grand Rapids, Michigan
    Site status: Not listed — confirm with the team
  • Precise Research Centers
    Flowood, Mississippi
    Site status: Not listed — confirm with the team
  • Altea Research Institute
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Center For Emotional Fitness
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • New York State Psychiatric Institute
    New York, New York
    Site status: Not listed — confirm with the team
  • Finger Lakes Clinical Research
    Rochester, New York
    Site status: Not listed — confirm with the team
  • The University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina
    Site status: Not listed — confirm with the team
  • University of Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • PeaceHealth Medical Group
    Eugene, Oregon
    Site status: Not listed — confirm with the team
  • University of Pennsylvania
    Philadelphia, Pennsylvania
    Site status: Not listed — confirm with the team
  • Vanderbilt University Medical Center
    Nashville, Tennessee
    Site status: Not listed — confirm with the team
  • Community Clinical Research, Inc.
    Austin, Texas
    Site status: Not listed — confirm with the team
  • University Hills Clinical Research
    Irving, Texas
    Site status: Not listed — confirm with the team
  • Psychiatric and Behavioral Solutions, LLC
    Salt Lake City, Utah
    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 psychotherapy or therapy 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.

What is a behavioral study?

This appears to be a behavioral / psychological / psychosocial study involving BI 409306, Placebo. 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 16 Years to 30 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 take part in sessions or exercises related to habits, thoughts, emotions, or behaviors. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

Could this study affect my mood, habits, motivation, or stress?

Behavioral studies can involve habits, emotions, motivation, stress, sleep, or ways of thinking. Ask whether the intervention could affect your mood or stress, and who to contact 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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