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RecruitingNCT06951711

KarXT for manic episodes in bipolarity type I

The registry lists this study as recruiting. Study locations are listed in the United States, in China, in Croatia, ... 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 China, in Croatia, and in India.

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 13, 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, China, Croatia, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT06951711
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-2)

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.

China · 6 sites
  • Local Institution - 0103
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0106
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0108
    Wuhan, Hubei
    Site status: Not Yet Recruiting
  • Local Institution - 0107
    Changsha, Hunan
    Site status: Not Yet Recruiting
  • Local Institution - 0105
    Jining Shi, Shandong
    Site status: Not Yet Recruiting
  • Local Institution - 0104
    Tianjin, Tianjin Municipality
    Site status: Not Yet Recruiting
Croatia · 5 sites
  • Local Institution - 0009
    Zagreb, City of Zagreb
    Site status: Withdrawn
  • Klinika za psihijatriju "Vrapče"
    Zagreb
    Site status: Recruiting
  • Klinika za psihijatriju "Vrapče"
    Zagreb
    Site status: Recruiting
  • Klinika za psihijatriju "Vrapče"
    Zagreb
    Site status: Recruiting
  • Psihijatrijska bolnica "Sveti Ivan"
    Zagreb
    Site status: Recruiting
India · 8 sites
  • GMERS Medical College and General Hospital
    Vadodara, Gujarat
    Site status: Recruiting
  • KLES Dr. Prabhakar Kore Hospital & M.R.C
    Belagavi, Karnataka
    Site status: Recruiting
  • Chethana Center for Neuropsychiatry
    Kozhikode, Kerala
    Site status: Recruiting
  • Dayanand Medical College and Hospital
    Ludhiana, Punjab
    Site status: Recruiting
  • Asha Hospital - Hyderabad
    Hyderabad, Telangana
    Site status: Recruiting
  • Local Institution - 0055
    Hyderabad, Telangana
    Site status: Not Yet Recruiting
  • Nil Ratan Sircar Medical College and Hospital
    Kolkata, West Bengal
    Site status: Recruiting
  • Local Institution - 0096
    Kolkata, West Bengal
    Site status: Not Yet Recruiting
Israel · 6 sites
  • Shalvata Mental Health Center
    Hod HaSharon, Central District
    Site status: Recruiting
  • Ness Ziona Mental Health Center
    Ness Ziona, Central District
    Site status: Recruiting
  • Local Institution - 0058
    Petah Tikva, Central District
    Site status: Not Yet Recruiting
  • Sheba Medical Center
    Ramat Gan, Central District
    Site status: Recruiting
  • Be'er Sheva Mental Health Center
    Beersheba, Southern District
    Site status: Recruiting
  • Kfar Shaul Mental Health Center
    Jerusalem
    Site status: Recruiting
Italy · 5 sites
  • Local Institution - 0001
    Milan, Lombardy
    Site status: Withdrawn
  • Local Institution - 0056
    Pisa, Tuscany
    Site status: Withdrawn
  • Local Institution - 0007
    Siena, Tuscany
    Site status: Withdrawn
  • Local Institution - 0041
    Ancona
    Site status: Withdrawn
  • Local Institution - 0040
    Genova
    Site status: Withdrawn
Romania · 11 sites
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital
    Bucharest, Bucharest
    Site status: Recruiting
  • Local Institution - 0097
    Bucharest, Bucharest
    Site status: Not Yet Recruiting
  • Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
    Bucharest
    Site status: Recruiting
  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
    Bucharest
    Site status: Recruiting
  • Local Institution - 0047
    Iași
    Site status: Not Yet Recruiting
  • Spitalul de Psihiatrie și Neurologie Brașov
    Sanpetru /Brasov
    Site status: Recruiting
Slovakia · 3 sites
  • Local Institution - 0073
    Košice, Košice Region
    Site status: Not Yet Recruiting
  • Univerzitna Nemocnica L. Pasteura Kosice
    Košice, Košice Region
    Site status: Recruiting
  • Crystal Comfort
    Vranov nad Topľou, Presov
    Site status: Recruiting
Spain · 3 sites
  • Local Institution - 0069
    Barcelona, Barcelona [Barcelona]
    Site status: Completed
  • Local Institution - 0039
    Bilbao, Basque Country
    Site status: Completed
  • Local Institution - 0044
    Barcelona, Catalunya [Cataluña]
    Site status: Completed
Sweden · 3 sites
  • Nacka Local Hospital
    Nacka, Stockholms Län [se-01]
    Site status: Recruiting
  • Local Institution - 0067
    Uppsala, Uppsala Län [se-03]
    Site status: Withdrawn
  • Local Institution - 0070
    Gothenburg, Västra Götalands Län [se-14]
    Site status: Withdrawn
Ukraine · 7 sites
  • Local Institution - 0088
    Dnipro, Dnipropetrovsk Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0092
    Hlevakha, Kyivska Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0093
    Oleksandrivka, Odesa Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0085
    Vinnytsia, Vinnytsia Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0084
    Kropyvnytskyi
    Site status: Not Yet Recruiting
  • Local Institution - 0094
    Odesa
    Site status: Not Yet Recruiting
  • Local Institution - 0090
    Poltava
    Site status: Not Yet Recruiting
United States · 28 sites
  • Pillar Clinical Research- Little Rock
    Little Rock, Arkansas
    Site status: Recruiting
  • Woodland Research Northwest
    Rogers, Arkansas
    Site status: Recruiting
  • Proscience Research Group
    Culver City, California
    Site status: Recruiting
  • Clinical Innovations, Inc. dba CITrials
    Riverside, California
    Site status: Recruiting
  • Collaborative Neuroscience Research, LLC
    Torrance, California
    Site status: Recruiting
  • Local Institution - 0036
    Hialeah Gardens, Florida
    Site status: Withdrawn
  • Behavioral Clinical Research
    Hollywood, Florida
    Site status: Recruiting
  • LCC Medical Research Institute
    Miami, Florida
    Site status: Recruiting
  • Innovative Clinical Research, Inc.
    Miami Lakes, Florida
    Site status: Recruiting
  • South Florida Research Phase I-IV
    Miami Springs, Florida
    Site status: Recruiting
  • Local Institution - 0019
    Tampa, Florida
    Site status: Withdrawn
  • Health Synergy Clinical Research
    West Palm Beach, Florida
    Site status: Recruiting
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Recruiting
  • CenExel iResearch, LLC
    Decatur, Georgia
    Site status: Recruiting
  • Local Institution - 0020
    Chicago, Illinois
    Site status: Not Yet Recruiting
  • CBH Health
    Gaithersburg, Maryland
    Site status: Recruiting
  • Precise Research Centers
    Flowood, Mississippi
    Site status: Recruiting
  • Arch Clinical Trials
    St Louis, Missouri
    Site status: Recruiting
  • Local Institution - 0076
    North Las Vegas, Nevada
    Site status: Withdrawn
  • Hassman Research Institute Marlton Site
    Marlton, New Jersey
    Site status: Recruiting
  • Local Institution - 0031
    Marlton, New Jersey
    Site status: Withdrawn
  • Local Institution - 0075
    Charlotte, North Carolina
    Site status: Withdrawn
  • University of Cincinnati Medical Center
    Cincinnati, Ohio
    Site status: Recruiting
  • Neuro-Behavioral Clinical Research
    North Canton, Ohio
    Site status: Recruiting
  • Adams Clinical Dallas
    DeSoto, Texas
    Site status: Recruiting
  • Local Institution - 0028
    Houston, Texas
    Site status: Withdrawn
  • Pillar Clinical Research - Richardson
    Richardson, Texas
    Site status: Recruiting
  • Pillar Clinical Research
    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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