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RecruitingNCT06951698

KarXT for manic episodes in bipolarity type I

The registry lists this study as recruiting. Study locations are listed in the United States, in Australia, in New Zealand, ... Confirm recruitment at each site. It is testing KarXT for manic episodes in bipolarity type I.

BipolarityDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether KarXT may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive KarXT, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Argentina, in Australia, and in Bulgaria.

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 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: June 11, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
274
Sponsor
Bristol-Myers Squibb
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug, OTHER
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Australia, New Zealand, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT06951698
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)

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.

Argentina · 5 sites
  • Hospital Italiano de Buenos Aires
    ABB, Buenos Aires F.D.
    Site status: Recruiting
  • Clinica del Prado
    Las Heras, Mendoza Province
    Site status: Recruiting
  • Sanatorio Morra S.A.
    Córdoba
    Site status: Recruiting
  • Local Institution - 0109
    Mendoza
    Site status: Not Yet Recruiting
  • Local Institution - 0140
    Santiago del Estero
    Site status: Not Yet Recruiting
Australia · 2 sites
  • Ramsay Clinic Northside
    St Leonards, New South Wales
    Site status: Recruiting
  • Ramsay Clinic New Farm
    Brisbane, Queensland
    Site status: Recruiting
Bulgaria · 7 sites
  • Local Institution - 0138
    Kazanlak, Stara Zagora
    Site status: Not Yet Recruiting
  • Center for Mental Health Prof. Dr. Ivan Temkov
    Burgas
    Site status: Recruiting
  • Local Institution - 0139
    Haskovo
    Site status: Not Yet Recruiting
  • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
    Novi Iskar
    Site status: Recruiting
  • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
    Pleven
    Site status: Recruiting
  • MHAT "Dr. Ival Seliminski"
    Sliven
    Site status: Recruiting
  • Mental Health Center - Vratsa
    Vratsa
    Site status: Recruiting
Hungary · 3 sites
  • Petz Aladar Egyetemi Oktato Korhaz
    Győr, Győr-Moson-Sopron
    Site status: Recruiting
  • Semmelweis Egyetem
    Budapest
    Site status: Recruiting
  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
    Budapest
    Site status: Recruiting
Japan · 19 sites
  • Local Institution - 0082
    Kōnan, Aichi-ken
    Site status: Active Not Recruiting
  • Okehazama Hospital
    Toyoake, Aichi-ken
    Site status: Recruiting
  • National Kohnodai Medical Center.
    Ichikawa, Chiba
    Site status: Recruiting
  • Local Institution - 0100
    Kitakyushu, Fukuoka
    Site status: Withdrawn
  • Obihiro Kosei Hospital
    Obihiro, Hokkaido
    Site status: Recruiting
  • Goryokai Medical Corporation - Goryokai Hospital
    Sapporo, Hokkaido
    Site status: Recruiting
  • Kansai Medical University Medical Center
    Moriguchi, Osaka
    Site status: Recruiting
  • Rainbow and Sea Hospital
    Karatsu-shi, Saga-ken
    Site status: Recruiting
  • Local Institution - 0081
    Iruma, Saitama
    Site status: Withdrawn
  • Saitama Konan Hospital
    Kumagaya, Saitama
    Site status: Recruiting
  • National Center of Neurology and Psychiatry
    Kodaira, Tokyo
    Site status: Recruiting
  • Narimasu Kosei Hospital
    tabashi City, Tokyo
    Site status: Recruiting
  • Kuramitsu Hospital
    Fukuoka
    Site status: Recruiting
  • Miyazaki Prefectural Miyazaki Hospital
    Miyazaki
    Site status: Recruiting
  • Osaka Metropolitan University Hospital
    Osaka
    Site status: Recruiting
  • Local Institution - 0084
    Osaka
    Site status: Withdrawn
  • Showa Medical University Karasuyama Hospital
    Tokyo
    Site status: Recruiting
  • Wakayama Medical University Hospital
    Wakayama
    Site status: Recruiting
  • Yamagata Sakuracho Hospital
    Yamagata
    Site status: Recruiting
New Zealand · 1 site
  • North Shore Hospital
    Auckland
    Site status: Recruiting
Poland · 7 sites
  • Centrum Medyczne HCP
    Poznan, Greater Poland Voivodeship
    Site status: Recruiting
  • Instytut Psychiatrii i Neurologii
    Warsaw, Masovian Voivodeship
    Site status: Recruiting
  • Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
    Bialystok, Podlaskie Voivodeship
    Site status: Recruiting
  • Local Institution - 0111
    Gdansk, Pomeranian Voivodeship
    Site status: Not Yet Recruiting
  • M2M Med
    Rybnik, Silesian Voivodeship
    Site status: Recruiting
  • Local Institution - 0102
    Sosnowiec, Silesian Voivodeship
    Site status: Not Yet Recruiting
  • Clinica Inventiva
    Tuszyn
    Site status: Recruiting
Ukraine · 7 sites
  • Local Institution - 0131
    Smila, Cherkasy Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0133
    Skarzhyntsi, Khmelnytskyi Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0130
    Dnipro
    Site status: Not Yet Recruiting
  • Local Institution - 0126
    Kropyvnytskyi
    Site status: Not Yet Recruiting
  • Local Institution - 0129
    Kyiv
    Site status: Not Yet Recruiting
  • Local Institution - 0132
    Poltava
    Site status: Not Yet Recruiting
  • Local Institution - 0137
    Ternopil
    Site status: Not Yet Recruiting
United States · 23 sites
  • Local Institution - 0058
    Bentonville, Arkansas
    Site status: Active Not Recruiting
  • Woodland International Research Group
    Little Rock, Arkansas
    Site status: Recruiting
  • Advanced Research Center Inc.
    Anaheim, California
    Site status: Recruiting
  • CITrials
    Bellflower, California
    Site status: Recruiting
  • Local Institution - 0014
    Cerritos, California
    Site status: Not Yet Recruiting
  • Collaborative Neuroscience Research, LLC
    Long Beach, California
    Site status: Recruiting
  • NRC Research Institute
    Los Angeles, California
    Site status: Recruiting
  • Catalina Research Institute, LLC
    Montclair, California
    Site status: Recruiting
  • Connecticut Mental Health Center
    New Haven, Connecticut
    Site status: Recruiting
  • Research Centers of America ( Hollywood )
    Hollywood, Florida
    Site status: Recruiting
  • Advanced Research Institute of Miami
    Homestead, Florida
    Site status: Recruiting
  • South Florida Research Phase I-IV
    Miami, Florida
    Site status: Recruiting
  • Innovative Clinical Research, Inc.
    Miami Lakes, Florida
    Site status: Recruiting
  • Local Institution - 0015
    Miami Lakes, Florida
    Site status: Not Yet Recruiting
  • Health Synergy Clinical Research
    West Palm Beach, Florida
    Site status: Recruiting
  • Synexus Clinical Research US, Inc.
    Atlanta, Georgia
    Site status: Recruiting
  • CenExel iResearch, LLC
    Savannah, Georgia
    Site status: Recruiting
  • Pillar Clinical Research -Chicago
    Chicago, Illinois
    Site status: Recruiting
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Recruiting
  • Neuro-Behavioral Clinical Research
    North Canton, Ohio
    Site status: Recruiting
  • Local Institution - 0141
    Austin, Texas
    Site status: Not Yet Recruiting
  • Local Institution - 0029
    Irving, Texas
    Site status: Withdrawn
  • Pillar Clinical Research - Richardson
    Richardson, Texas
    Site status: Recruiting

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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 KarXT, Placebo. 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 Bristol-Myers Squibb, which appears to be a pharmaceutical company. The listed contact or investigator is Bristol-Myers Squibb, affiliated with Bristol-Myers Squibb. Sponsor website: https://www.bms.com. 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 recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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