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RecruitingNCT07140913

KarXT for manic episodes in bipolarity type I

The registry lists this study as recruiting. Study locations are listed in the United States, in France, in Argentina, ... Confirm recruitment at each site. It is testing KarXT for manic episodes in bipolarity type I, including participants taking lithium, valproate, or lamotrigine.

Bipolarity, ManiaDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

What is this study testing?

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

What would participation involve?

Participants may receive Adjunctive KarXT, 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 Bulgaria, and in China.

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: October 8, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
424
Sponsor
Bristol-Myers Squibb
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, France, Argentina, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT07140913
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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 · 6 sites
  • Local Institution - 0011
    ABB, Buenos Aires F.D.
    Site status: Not Yet Recruiting
  • Local Institution - 0010
    Córdoba
    Site status: Not Yet Recruiting
  • Local Institution - 0012
    Córdoba
    Site status: Not Yet Recruiting
  • Local Institution - 0008
    Córdoba
    Site status: Not Yet Recruiting
  • Local Institution - 0009
    Mendoza
    Site status: Not Yet Recruiting
  • Local Institution - 0114
    Santiago del Estero
    Site status: Not Yet Recruiting
Bulgaria · 5 sites
  • Local Institution - 0184
    Kazanlak, Stara Zagora
    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
  • Local Institution - 0181
    Sliven
    Site status: Not Yet Recruiting
  • Local Institution - 0086
    Targovishte
    Site status: Not Yet Recruiting
China · 11 sites
  • Local Institution - 0185
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0190
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0191
    Guangzhou, Guangdong
    Site status: Not Yet Recruiting
  • Local Institution - 0193
    Baoding, Hebei
    Site status: Not Yet Recruiting
  • Local Institution - 0187
    Shijiazhuang, Hebei
    Site status: Not Yet Recruiting
  • Local Institution - 0196
    Nanjing, Jiangsu
    Site status: Not Yet Recruiting
  • Local Institution - 0186
    Xi'an, Shaanxi
    Site status: Not Yet Recruiting
  • Local Institution - 0192
    Chengdu, Sichuan
    Site status: Not Yet Recruiting
  • Local Institution - 0188
    Tianjin, Tianjin Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0197
    Ningbo, Zhejiang
    Site status: Not Yet Recruiting
  • Local Institution - 0195
    Changsha
    Site status: Not Yet Recruiting
Denmark · 3 sites
  • Local Institution - 0088
    Hillerød, Capital Region
    Site status: Not Yet Recruiting
  • Local Institution - 0054
    Aalborg, North Denmark
    Site status: Not Yet Recruiting
  • Local Institution - 0091
    Glostrup Municipality
    Site status: Not Yet Recruiting
France · 5 sites
  • Local Institution - 0126
    Nice, Alpes-Maritimes
    Site status: Not Yet Recruiting
  • Local Institution - 0085
    Clermont-Ferrand, Puy-de-Dôme
    Site status: Not Yet Recruiting
  • Local Institution - 0087
    Marseille
    Site status: Withdrawn
  • Local Institution - 0129
    Montpellier
    Site status: Not Yet Recruiting
  • Local Institution - 0089
    Paris
    Site status: Withdrawn
India · 4 sites
  • Local Institution - 0121
    Mangalore, Karnataka
    Site status: Not Yet Recruiting
  • Local Institution - 0123
    Madurai, Tamil Nadu
    Site status: Not Yet Recruiting
  • Local Institution - 0118
    Kolkata, West Bengal
    Site status: Not Yet Recruiting
  • Local Institution - 0116
    Kolkata
    Site status: Not Yet Recruiting
Israel · 5 sites
  • Local Institution - 0052
    Hod HaSharon, Central District
    Site status: Not Yet Recruiting
  • Sheba Medical Center
    Ramat Gan, Central District
    Site status: Recruiting
  • Local Institution - 0053
    Ashkelon, Southern District
    Site status: Not Yet Recruiting
  • Be'er Sheva Mental Health Center
    Beersheba, Southern District
    Site status: Recruiting
  • Local Institution - 0083
    Jerusalem
    Site status: Not Yet Recruiting
Italy · 5 sites
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    Milan, Lombardy
    Site status: Recruiting
  • Local Institution - 0005
    Pisa, Tuscany
    Site status: Not Yet Recruiting
  • Azienda Ospedaliero Universitaria Senese
    Siena, Tuscany
    Site status: Recruiting
  • Local Institution - 0004
    Ancona
    Site status: Not Yet Recruiting
  • Local Institution - 0002
    Genova
    Site status: Not Yet Recruiting
Japan · 13 sites
  • Okehazama Hospital
    Toyoake, Aichi-ken
    Site status: Recruiting
  • Local Institution - 0205
    Ichikawa, Chiba
    Site status: Not Yet Recruiting
  • Local Institution - 0172
    Iizuka, Fukuoka
    Site status: Withdrawn
  • Local Institution - 0141
    Kitakyushu-shi, Fukuoka
    Site status: Withdrawn
  • Goryokai Medical Corporation - Goryokai Hospital
    Sapporo, Hokkaido
    Site status: Recruiting
  • Local Institution - 0107
    Yokohama, Kanagawa
    Site status: Not Yet Recruiting
  • Rainbow and Sea Hospital
    Karatsu, Saga-ken
    Site status: Recruiting
  • Juntendo University Hospital
    Bunkyo-ku, Tokyo
    Site status: Recruiting
  • Nippon Medical School Hospital
    Bunkyo-ku, Tokyo
    Site status: Recruiting
  • Local Institution - 0201
    Kodaira, Tokyo
    Site status: Not Yet Recruiting
  • Narimasu Kosei Hospital
    tabashi City, Tokyo
    Site status: Recruiting
  • Kuramitsu Hospital
    Fukuoka
    Site status: Recruiting
  • Kochi Health Sciences Center
    Kochi
    Site status: Recruiting
Poland · 4 sites
  • Instytut Psychiatrii i Neurologii
    Warsaw, Masovian Voivodeship
    Site status: Recruiting
  • Uniwersyteckie Centrum Kliniczne
    Gdansk, Pomeranian Voivodeship
    Site status: Recruiting
  • Local Institution - 0103
    Rybnik, Silesian Voivodeship
    Site status: Not Yet Recruiting
  • Clinica Inventiva
    Tuszyn
    Site status: Recruiting
Romania · 11 sites
  • Local Institution - 0093
    Bucharest, Bucharest
    Site status: Not Yet 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
  • Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
    Bucharest
    Site status: Recruiting
  • Local Institution - 0099
    Bucharest
    Site status: Not Yet Recruiting
  • Local Institution - 0203
    Bucharest
    Site status: Not Yet Recruiting
  • Local Institution - 0097
    Iași
    Site status: Not Yet Recruiting
  • Spitalul de Psihiatrie și Neurologie Brașov
    Sanpetru /Brasov
    Site status: Recruiting
  • Local Institution - 0101
    Sibiu
    Site status: Not Yet Recruiting
Ukraine · 12 sites
  • Local Institution - 0167
    Smila, Cherkasy Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0165
    Dnipro, Dnipropetrovsk Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0178
    Skarzhyntsi, Khmelnytskyi Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0163
    Nove, Kirovohrad Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0169
    Hlevakha, Kyivska Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0162
    Kyiv, Kyivska Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0164
    Lviv, Lviv Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0170
    Odesa, Odesa Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0168
    Vinnytsia, Vinnytsia Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0171
    Odesa
    Site status: Not Yet Recruiting
  • Local Institution - 0177
    Poltava
    Site status: Not Yet Recruiting
  • Local Institution - 0206
    Ternopil
    Site status: Not Yet Recruiting
United States · 20 sites
  • Pillar Clinical Research - Bentonville
    Bentonville, Arkansas
    Site status: Recruiting
  • Pillar Clinical Research- Little Rock
    Little Rock, Arkansas
    Site status: Recruiting
  • Clinical Innovations, Inc. dba CITrials
    Bellflower, California
    Site status: Recruiting
  • Inland Psychiatric Medical Group.
    Chino, California
    Site status: Recruiting
  • Proscience Research Group
    Culver City, California
    Site status: Recruiting
  • Omega Clinical Trials - La Habra
    La Habra, California
    Site status: Recruiting
  • Catalina Research Institute, LLC
    Montclair, California
    Site status: Recruiting
  • NRC Research Institute
    Orange, California
    Site status: Recruiting
  • Clinical Innovations, Inc. dba CITrials
    Riverside, California
    Site status: Recruiting
  • Velocity Clinical Research, Hallandale Beach
    Hallandale, Florida
    Site status: Recruiting
  • South Florida Research Phase I-IV
    Miami, Florida
    Site status: Recruiting
  • Health Synergy Clinical Research
    West Palm Beach, Florida
    Site status: Recruiting
  • CenExel iResearch, LLC
    Savannah, Georgia
    Site status: Recruiting
  • Pillar Clinical Research -Chicago
    Chicago, Illinois
    Site status: Recruiting
  • Arch Clinical Trials
    St Louis, Missouri
    Site status: Recruiting
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Recruiting
  • Community Clinical Research
    Austin, Texas
    Site status: Recruiting
  • Elevate Clinical Research-Houston
    Houston, Texas
    Site status: Recruiting
  • Prime Clinical Research - Mansfield
    Mansfield, Texas
    Site status: Recruiting
  • Pillar Clinical Research - Richardson
    Richardson, Texas
    Site status: Recruiting

Want help reviewing this study?

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Study ID: NCT07140913. 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. It includes a comparison with placebo. 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 Xanomeline/Trospium Chloride, 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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