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CompletedNCT03287869

Brexpiprazole for Bipolarity type I; Acute Mania

This study is completed in the United States, in Bulgaria, in Croatia, .... It is testing brexpiprazole for Bipolarity type I; Acute Mania.

Bipolarity, Acute ManiaDrugFrom 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 Brexpiprazole may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive Brexpiprazole, attend study visits with the research team. The registry lists locations in Bulgaria, in Croatia, and in Poland.

Who is it mainly for?

This study appears to be mainly for adults with bipolarity.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is 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 24, 2017
Recruitment status
Completed
Enrollment listed in the registry
381
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Bulgaria, Croatia, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT03287869
Official title
A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

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.

Bulgaria · 9 sites
  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Condition
    Burgas
    Site status: Not listed — confirm with the team
  • State Psychiatry Hospital - Kardzhali,Third Male Department, First Female Department
    Kardzhali
    Site status: Not listed — confirm with the team
  • State Psychiatry Hospital Sv. Ivan Rilski, First Male department, First Female Department
    Novi Iskar
    Site status: Not listed — confirm with the team
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Clinic of Psychiatry
    Plovdiv
    Site status: Not listed — confirm with the team
  • "Mental Health Centre-Ruse" EOOD, Male department for persons with severe mental disorders, Female department for persons with severe mental disorders
    Rousse
    Site status: Not listed — confirm with the team
  • University Multiprofile Hospital for Active Treatment -Alexandrovska EAD, Clinic of Psychiatry, First Department of Psychiatry
    Sofia
    Site status: Not listed — confirm with the team
  • Multiprofile Hospital for Active Treatment - Targovishte AD, Department of Psychiatry
    Targovishte
    Site status: Not listed — confirm with the team
  • Mental Health Center - Veliko Tarnovo EOOD, Department of Psychiatry for Active Treatment of Persons with Severe Mental Disorders
    Veliko Tarnovo
    Site status: Not listed — confirm with the team
  • Mental Health Center - Vratsa EOOD, Department of Psychiatry
    Vratsa
    Site status: Not listed — confirm with the team
Croatia · 2 sites
  • CHC Rijeka-Clinic for Psychiatrics
    Rijeka
    Site status: Not listed — confirm with the team
  • Poliklinika Neuron /Polyclinic Neuron
    Zagreb
    Site status: Not listed — confirm with the team
Poland · 2 sites
  • Indywidualna Specjalistyczna Praktyka Lekarska Wieslaw Jerzy Cubala
    Gdansk
    Site status: Not listed — confirm with the team
  • NZOZ Prywatna Klinika Psychiatryczna Inventiva
    Tuszyn
    Site status: Not listed — confirm with the team
Serbia · 6 sites
  • CHC Dr Dragisa Misovic
    Belgrade
    Site status: Not listed — confirm with the team
  • Clinic for Psychiatric Disorders, Dr Laza Lazarevic
    Belgrade
    Site status: Not listed — confirm with the team
  • Clinic for Psychiatry
    Belgrade
    Site status: Not listed — confirm with the team
  • Specialized Hospital for Psychiatry Diseases Kovin
    Kovin
    Site status: Not listed — confirm with the team
  • Clinical Center Kragujevac, Clinic of Psychiatry
    Kragujevac
    Site status: Not listed — confirm with the team
  • Klinika za psihijariju, Klinicki Centar Vojvodine
    Novi Sad
    Site status: Not listed — confirm with the team
Ukraine · 10 sites
  • Regional Clinical Hospital n.a I.I. Mechnicov
    Dnipro
    Site status: Not listed — confirm with the team
  • SI of Neurology Psychiatry and Narcology NAMS
    Kharkiv
    Site status: Not listed — confirm with the team
  • Kherson Regional Psychiatric Hospital
    Kherson
    Site status: Not listed — confirm with the team
  • Kyiv Regional Medical Incorporation Psychiatry
    Kyiv
    Site status: Not listed — confirm with the team
  • CI of LOR Lviv Regional Clinical Psychiatric Hospital, Department #25
    Lviv
    Site status: Not listed — confirm with the team
  • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", department #20
    Lviv
    Site status: Not listed — confirm with the team
  • Odesa Regional Psychiatric Hospital 2
    Odesa
    Site status: Not listed — confirm with the team
  • Maltsev Regional Clinical Psychiatric Hospital
    Poltava
    Site status: Not listed — confirm with the team
  • Ternopil Regional Municipal Clinical Psychoneurological Hospital
    Ternopil
    Site status: Not listed — confirm with the team
  • O.I. Yushenko Vinnitsa Regional Clinic
    Vinnitsa
    Site status: Not listed — confirm with the team
United States · 44 sites
  • Woodland International Research Group
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Woodland Research Northwest, LLC
    Rogers, Arkansas
    Site status: Not listed — confirm with the team
  • Citrials Inc.
    Bellflower, California
    Site status: Not listed — confirm with the team
  • Radiant Research
    Cerritos, California
    Site status: Not listed — confirm with the team
  • ProScience Research Group
    Culver City, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Network, LLC
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Behavioral Research Specialists, LLC
    Glendale, California
    Site status: Not listed — confirm with the team
  • Apostle Clinical Trials
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Pacific Research Partners, LLC
    Oakland, California
    Site status: Not listed — confirm with the team
  • NRC Research Institute
    Orange, California
    Site status: Not listed — confirm with the team
  • Asclepes Research Centers, PC
    Panorama City, California
    Site status: Not listed — confirm with the team
  • CI Trials
    Riverside, California
    Site status: Not listed — confirm with the team
  • CNRI-San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • Artemis Institute for Clinical Research
    San Diego, California
    Site status: Not listed — confirm with the team
  • Sharp Mesa Vista Hospital
    San Diego, California
    Site status: Not listed — confirm with the team
  • CI Trials
    Santa Ana, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Network, LLC
    Torrance, California
    Site status: Not listed — confirm with the team
  • Shreenath Clinical Service
    Yorba Linda, California
    Site status: Not listed — confirm with the team
  • Optimus U Corp
    Coral Gables, Florida
    Site status: Not listed — confirm with the team
  • Segal Trials
    Fort Lauderdale, Florida
    Site status: Not listed — confirm with the team
  • Galiz Research
    Hialeah, Florida
    Site status: Not listed — confirm with the team
  • Research Centers of America, LLC
    Hollywood, Florida
    Site status: Not listed — confirm with the team
  • Florida Behavioral Medicine
    Largo, Florida
    Site status: Not listed — confirm with the team
  • University of South Florida Board of Trustees
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • iResearch Atlanta, LLC
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Alexian Brothers Center for Psychiatric Research
    Hoffman Estates, Illinois
    Site status: Not listed — confirm with the team
  • NeuroPsychiatric Research
    Winfield, Illinois
    Site status: Not listed — confirm with the team
  • Louisiana Clinical Research
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • CBH Health
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • St. Charles Psychiatric Associates
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Arch Clinical Trials, 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
  • Hassman Research Institute, LLC
    Berlin, New Jersey
    Site status: Not listed — confirm with the team
  • Clinical Trials of America-NC, LLC
    Hickory, North Carolina
    Site status: Not listed — confirm with the team
  • Richard H Weisler, MD PA Associates
    Raleigh, North Carolina
    Site status: Not listed — confirm with the team
  • SP Research PLLC
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Cutting Edge Research Group
    Oklahoma City, Oklahoma
    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
  • North Texas Clinical Trials
    Fort Worth, Texas
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research LLC
    Garland, Texas
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research, LLC
    Richardson, Texas
    Site status: Not listed — confirm with the team
  • Core Clinical Research
    Everett, Washington
    Site status: Not listed — confirm with the team
  • Mid Columbia Research
    Richland, Washington
    Site status: Not listed — confirm with the team

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Study ID: NCT03287869. 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 bipolarity. 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 Brexpiprazole. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with bipolarity; age range: From 18 Years to 65 Years. The criteria appear fairly specific, 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 Otsuka Pharmaceutical Development & Commercialization, Inc., which appears to be a pharmaceutical company. Sponsor website: https://www.otsuka.co.jp/en/. 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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