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RecruitingNCT07140913

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolarity type I Taking Lithium, Valproate, or Lamotrigine

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States, Argentina, Bulgaria, China, Denmark, France, India, Israel, Italy, Japan, Poland, Romania, and Ukraine.

BipolarityDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

This study is looking at evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolarity type I for people with Mania or bipolarity. Some participants may receive placebo instead of the study treatment, and direct benefit is not guaranteed.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including Pillar Clinical Research - Bentonville, Pillar Clinical Research- Little Rock, and Clinical Innovations, Inc dba CITrials in Bellflower. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually matching the main diagnosis and meeting the main study requirements, while common reasons not to take part include active substance or alcohol problems that could affect the results and safety concerns that need urgent care first. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

Public study data

Key study information

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
Condition
Mania; Bipolar Disorder
Study status
Recruiting
Phase
Phase 3
Sponsor / lead affiliation
Bristol-Myers Squibb
Intervention
Xanomeline/Trospium Chloride, Placebo
Location / country
United States, Argentina, Bulgaria, China, Denmark, France, India, Israel, Italy, Japan, Poland, Romania, Ukraine
Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, First line of the email MUST contain NCT # and Site #., Fayz Hudefi, Site 0029, Leslie Smith, Site 0018, Gerald Maguire, Site 0110, Nandita Puchakayala, Site 0049, Marina Bussel, Site 0014, Wakelin McNeel, Site 0151, Stephen Volk, Site 0037, Tony Ortiz, Site 0148, Evagelos Coskinas, Site 0106, Beth Safirstein, Site 0015, Silvia Silva Duluc, Site 0021, Mohammad Nisar, Site 0016, Yael Elfassy, Site 0136, Roueen Rafeyan, Site 0017, Junaid Syed, Site 0023, Peter Weiden, Site 0032, David Brown, Site 0026, Site 0160, Jamie Alexander, Site 0156, Scott Bartley, Site 0033, Site 0011, Site 0010, Site 0012, Site 0008, Site 0009, Site 0114, Site 0184, Site 0124, Maya Stoimenova - Popova, Site 0125, Site 0084, Site 0181, Site 0086, Site 0185, Site 0190, Site 0191, Site 0193, Site 0187, Site 0196, Site 0186, Site 0192, Site 0188, Site 0197, Site 0195, Site 0088, Site 0054, Site 0091, Site 0126, Site 0085, Site 0129, Site 0121, Site 0123, Site 0118, Site 0116, Site 0052, Linda Levi-Haramati, Site 0050, Site 0053, Site 0199, Site 0200, Site 0083, Site 0003, Site 0005, Site 0001, Site 0004, Site 0002, kiyoshi Fujita, Site 0173, Site 0205, Kimihiro Nakajima, Site 0108, Site 0107, Taro Shindo, Site 0175, Site 0180, Site 0139, Site 0201, Site 0176, Noriko Tamaru, Site 0174, Ken Sawada, Site 0142, Site 0103, Jaroslaw Strzelec, Site 0082, Site 0093, Valentin Matei, Site 0092, ADELA CIOBANU, Site 0098, Laura Cristina Dolis, Site 0094, Site 0102, Site 0099, Site 0203, Site 0097, Site 0095, Site 0101, Site 0167, Site 0165, Site 0178, Site 0163, Site 0169, Site 0162, Site 0164, Site 0206, Site 0168, Site 0170, Site 0171, Site 0177
Email
Clinical.Trials@bms.com
Phone
855-907-3286, 479-367-2688, 501-350-3285, 562-249-6956, 909-488-9116, 424-227-8127, 562-690-2200, 909-590-8409, 714-289-1100, 951-300-4924, 305-669-6166, 786-831-7303, 912-744-0800, 312-865-6336, 314-771-6387, 917-701-7484, 512-323-2622, 817-907-7330, 214-396-4844, +359888227165, 0585950299, 0562971361, +81-11-771-5660, 0955770711, +81-92-811-1821, +81-88-837-3000, 602305132, +40721243869, 0040723671301, 0040757243543
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating Xanomeline/Trospium Chloride, Placebo in a structured research setting. For people exploring bipolarity research, clear information about the goal, status, contacts, and official source can support better questions before any decision.

Before joining

Questions to ask before joining

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record
Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

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Study reference: NCT07140913. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor
Bristol-Myers Squibb
Sponsor type
Pharmaceutical company
Main activity
medication or study treatment
Intervention
Xanomeline/Trospium Chloride, Placebo
Time commitment
long follow-up or multiple visits
Study phase
Phase 3
Enrollment
Not available
Recruitment status
Recruiting
Source
Official registry link
FAQ

Questions about this study

What is A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolarity type I Taking Lithium, Valproate, or Lamotrigine?

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.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Bristol-Myers Squibb, a pharmaceutical company. The company develops medicines across several therapeutic areas, including oncology, hematology, immunology, cardiovascular disease, and neuroscience. The sponsor is based in the United States. Sponsor website: https://www.bms.com. You can verify the sponsor and study responsibility in the official registry record.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve medication or study treatment, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is Phase 3. Earlier-phase studies are often more focused on safety, dose, or feasibility, while later-phase studies usually involve more participants and more information about the intervention. The official source record gives the most accurate details. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.

A Study to Evaluate the Efficacy and Safety of. — Bipolarity Clinical Trial | HopeStage