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RecruitingNCT06929273

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 France, ... 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, attend study visits with the research team. 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 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: July 18, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
450
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, Australia, France, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT06929273
Official title
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

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 · 3 sites
  • Local Institution - 0128
    ABB, Buenos Aires F.D.
    Site status: Not Yet Recruiting
  • Sanatorio Morra S.A.
    Córdoba
    Site status: Recruiting
  • Local Institution - 0126
    Mendoza
    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 - 0188
    Kazanlak, Stara Zagora
    Site status: Not Yet Recruiting
  • Center for Mental Health Prof. Dr. Ivan Temkov
    Burgas
    Site status: Recruiting
  • Local Institution - 0191
    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
China · 10 sites
  • Local Institution - 0177
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0174
    Beijing, Beijing Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0175
    Guangzhou, Guangdong
    Site status: Not Yet Recruiting
  • Local Institution - 0181
    Baoding, Hebei
    Site status: Not Yet Recruiting
  • Local Institution - 0184
    Changsha, Hunan
    Site status: Not Yet Recruiting
  • Local Institution - 0180
    Nanjing, Jiangsu
    Site status: Not Yet Recruiting
  • Xi An Mental Health Center
    Xi'an, Shaanxi
    Site status: Recruiting
  • Local Institution - 0179
    Chengdu, Sichuan
    Site status: Not Yet Recruiting
  • Local Institution - 0183
    Tianjin, Tianjin Municipality
    Site status: Not Yet Recruiting
  • Local Institution - 0182
    Ningbo, Zhejiang
    Site status: Not Yet Recruiting
Croatia · 5 sites
  • Local Institution - 0018
    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
Denmark · 2 sites
  • Aalborg Universitetshospital Psykiatrien
    Gistrup
    Site status: Recruiting
  • Glostrup Hospital
    Glostrup Municipality
    Site status: Recruiting
France · 3 sites
  • Local Institution - 0170
    Nice, Alpes-Maritimes
    Site status: Not Yet Recruiting
  • Local Institution - 0171
    Clermont-Ferrand
    Site status: Not Yet Recruiting
  • Local Institution - 0172
    Montpellier
    Site status: Not Yet 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
India · 10 sites
  • Local Institution - 0111
    Vadodara, Gujarat
    Site status: Not Yet Recruiting
  • Local Institution - 0132
    Belagavi, Karnataka
    Site status: Not Yet Recruiting
  • Local Institution - 0190
    Mangalore, Karnataka
    Site status: Not Yet Recruiting
  • Chethana Center for Neuropsychiatry
    Kozhikode, Kerala
    Site status: Recruiting
  • Dayanand Medical College and Hospital
    Ludhiana, Punjab
    Site status: Recruiting
  • Local Institution - 0158
    Madurai, Tamil Nadu
    Site status: Not Yet Recruiting
  • Asha Hospital - Hyderabad
    Hyderabad, Telangana
    Site status: Recruiting
  • Local Institution - 0080
    Hyderabad, Telangana
    Site status: Not Yet Recruiting
  • Nil Ratan Sircar Medical College and Hospital
    Kolkata, West Bengal
    Site status: Recruiting
  • Local Institution - 0160
    Kolkata, West Bengal
    Site status: Not Yet Recruiting
Israel · 8 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 - 0084
    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
  • Barzilai Medical Center
    Ashkelon
    Site status: Recruiting
  • Local Institution - 0168
    Jerusalem
    Site status: Not Yet Recruiting
  • Kfar Shaul Mental Health Center
    Jerusalem
    Site status: Recruiting
Italy · 5 sites
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    Milan, Lombardy
    Site status: Recruiting
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, Tuscany
    Site status: Recruiting
  • Azienda Ospedaliero Universitaria Senese
    Siena, Tuscany
    Site status: Recruiting
  • Azienda Ospedaliero Universitaria delle Marche
    Ancona
    Site status: Recruiting
  • IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
    Genova
    Site status: Recruiting
Japan · 24 sites
  • Hotei Hospital
    Kōnan, Aichi-ken
    Site status: Recruiting
  • Okehazama Hospital
    Toyoake, Aichi-ken
    Site status: Recruiting
  • National Kohnodai Medical Center.
    Ichikawa, Chiba
    Site status: Recruiting
  • Local Institution - 0166
    Iizuka, Fukuoka
    Site status: Withdrawn
  • Local Institution - 0063
    Kitakyushu, Fukuoka
    Site status: Withdrawn
  • Obihiro Kosei Hospital
    Obihiro, Hokkaido
    Site status: Recruiting
  • Goryokai Medical Corporation - Goryokai Hospital
    Sapporo, Hokkaido
    Site status: Recruiting
  • Hino Hospital - Yokohama
    Yokohama, Kanagawa
    Site status: Recruiting
  • Kansai Medical University Medical Center
    Moriguchi, Osaka
    Site status: Recruiting
  • Local Institution - 0007
    Sakai-shi, Osaka
    Site status: Withdrawn
  • Rainbow and Sea Hospital
    Karatsu-shi, Saga-ken
    Site status: Recruiting
  • Local Institution - 0016
    Iruma, Saitama
    Site status: Withdrawn
  • Saitama Konan Hospital
    Kumagaya, Saitama
    Site status: Recruiting
  • Juntendo University Hospital
    Bunkyo-ku, Tokyo
    Site status: Recruiting
  • Nippon Medical School Hospital
    Bunkyo-ku, Tokyo
    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
  • Kochi Health Sciences Center
    Kochi
    Site status: Recruiting
  • Miyazaki Prefectural Miyazaki Hospital
    Miyazaki
    Site status: Recruiting
  • Osaka Metropolitan University Hospital
    Osaka
    Site status: Recruiting
  • 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 · 6 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
  • Uniwersyteckie Centrum Kliniczne
    Gdansk, Pomeranian Voivodeship
    Site status: Recruiting
  • M2M Med
    Rybnik, Silesian Voivodeship
    Site status: Recruiting
  • Clinica Inventiva
    Tuszyn
    Site status: Recruiting
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
  • Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
    Bucharest
    Site status: 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 - 0097
    Iași
    Site status: Not Yet Recruiting
  • Spitalul de Psihiatrie și Neurologie Brașov
    Sanpetru /Brasov
    Site status: Recruiting
Slovakia · 3 sites
  • Local Institution - 0119
    Košice, Košice Region
    Site status: Not Yet Recruiting
  • Univerzitna Nemocnica L. Pasteura Kosice
    Košice, Košice Region
    Site status: Recruiting
  • Local Institution - 0117
    Vranov nad Topľou, Presov
    Site status: Not Yet Recruiting
Spain · 3 sites
  • Local Institution - 0115
    Barcelona, Barcelona [Barcelona]
    Site status: Completed
  • Osi Bilbao-Basurto
    Bilbao, Basque Country
    Site status: Recruiting
  • Hospital Clínic de Barcelona
    Barcelona, Catalunya [Cataluña]
    Site status: Recruiting
Sweden · 3 sites
  • Nacka Local Hospital
    Nacka, Stockholms Län [se-01]
    Site status: Recruiting
  • Local Institution - 0112
    Uppsala, Uppsala Län [se-03]
    Site status: Withdrawn
  • Local Institution - 0116
    Gothenburg, Västra Götalands Län [se-14]
    Site status: Withdrawn
Ukraine · 12 sites
  • Local Institution - 0152
    Smila, Cherkasy Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0146
    Skarzhyntsi, Khmelnytskyi Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0143
    Hlevakha, Kyivska Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0147
    Lviv, Lviv Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0145
    Odesa, Odesa Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0148
    Vinnytsia, Vinnytsia Oblast
    Site status: Not Yet Recruiting
  • Local Institution - 0149
    Dnipro
    Site status: Not Yet Recruiting
  • Local Institution - 0151
    Kropyvnytskyi
    Site status: Not Yet Recruiting
  • Local Institution - 0150
    Kyiv
    Site status: Not Yet Recruiting
  • Local Institution - 0144
    Odesa
    Site status: Not Yet Recruiting
  • Local Institution - 0141
    Poltava
    Site status: Not Yet Recruiting
  • Local Institution - 0189
    Ternopil
    Site status: Not Yet Recruiting
United States · 61 sites
  • Local Institution - 0120
    Glendale, Arizona
    Site status: Not Yet Recruiting
  • Local Institution - 0204
    Scottsdale, Arizona
    Site status: Not Yet Recruiting
  • Local Institution - 0205
    Tucson, Arizona
    Site status: Not Yet Recruiting
  • Pillar Clinical Research - Richardson
    Bentonville, Arkansas
    Site status: Recruiting
  • Pillar Clinical Research- Little Rock
    Little Rock, Arkansas
    Site status: Recruiting
  • Woodland International Research Group
    Little Rock, Arkansas
    Site status: Recruiting
  • Woodland Research Northwest
    Rogers, Arkansas
    Site status: Recruiting
  • Advanced Research Center Inc.
    Anaheim, California
    Site status: Recruiting
  • Clinical Innovations, Inc. dba CITrials
    Bellflower, California
    Site status: Recruiting
  • Local Institution - 0044
    Cerritos, California
    Site status: Not Yet Recruiting
  • Local Institution - 0201
    Cerritos, California
    Site status: Not Yet Recruiting
  • Inland Psychiatric Medical Group - Chino
    Chino, California
    Site status: Recruiting
  • Proscience Research Group
    Culver City, California
    Site status: Recruiting
  • Collaborative Neuroscience Research, LLC
    Garden Grove, California
    Site status: Recruiting
  • Omega Clinical Trials - La Habra
    La Habra, California
    Site status: Recruiting
  • Catalina Research Institute, LLC
    Montclair, California
    Site status: Recruiting
  • Local Institution - 0200
    Northridge, California
    Site status: Not Yet Recruiting
  • NRC Research Institute
    Orange, California
    Site status: Recruiting
  • Clinical Innovations, Inc. dba CITrials
    Riverside, California
    Site status: Recruiting
  • Local Institution - 0136
    Santa Ana, California
    Site status: Withdrawn
  • Collaborative Neuroscience Research, LLC
    Torrance, California
    Site status: Recruiting
  • Local Institution - 0203
    Colorado Springs, Colorado
    Site status: Not Yet Recruiting
  • Yale New Haven Hospital-Smilow Cancer Center
    New Haven, Connecticut
    Site status: Recruiting
  • Velocity Clinical Research, Hallandale Beach
    Hallandale, Florida
    Site status: Recruiting
  • Local Institution - 0026
    Hialeah Gardens, Florida
    Site status: Not Yet Recruiting
  • Behavioral Clinical Research
    Hollywood, Florida
    Site status: Recruiting
  • Research Centers of America ( Hollywood )
    Hollywood, Florida
    Site status: Recruiting
  • LCC Medical Research Institute
    Miami, Florida
    Site status: Recruiting
  • Advanced Research Institute of Miami
    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 - 0045
    St. Petersburg, 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
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Recruiting
  • CenExel iResearch, LLC
    Decatur, Georgia
    Site status: Recruiting
  • CenExel iResearch, LLC
    Savannah, Georgia
    Site status: Recruiting
  • Local Institution - 0031
    Chicago, Illinois
    Site status: Not Yet Recruiting
  • Pillar Clinical Research -Chicago
    Chicago, Illinois
    Site status: 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 - 0197
    Lincoln, Nebraska
    Site status: Not Yet Recruiting
  • Local Institution - 0121
    North Las Vegas, Nevada
    Site status: Not Yet Recruiting
  • Local Institution - 0122
    North Las Vegas, Nevada
    Site status: Withdrawn
  • Hassman Research Institute Marlton Site
    Marlton, New Jersey
    Site status: Recruiting
  • Local Institution - 0058
    Marlton, New Jersey
    Site status: Withdrawn
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Recruiting
  • Local Institution - 0124
    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
  • Local Institution - 0202
    West Chester, Ohio
    Site status: Not Yet Recruiting
  • Community Clinical Research
    Austin, Texas
    Site status: Recruiting
  • Local Institution - 0199
    Carrollton, Texas
    Site status: Not Yet Recruiting
  • Adams Clinical Dallas
    DeSoto, Texas
    Site status: Recruiting
  • Local Institution - 0046
    Houston, Texas
    Site status: Withdrawn
  • Elevate Clinical Research-Houston
    Houston, Texas
    Site status: Recruiting
  • Local Institution - 0036
    Irving, Texas
    Site status: Withdrawn
  • Prime Clinical Research - Mansfield
    Mansfield, Texas
    Site status: Recruiting
  • Pillar Clinical Research - Richardson
    Richardson, Texas
    Site status: Recruiting
  • Local Institution - 0198
    Wichita Falls, Texas
    Site status: Not Yet Recruiting

Want help reviewing this study?

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Study ID: NCT06929273. 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 KarXT, Lithium, Valproate, Lamotrigine. 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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