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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
Researchers compare KarXT with placebo, each added to lithium, valproate or lamotrigine, in people with bipolarity type I experiencing mania, with or without mixed features. They want to know whether adding KarXT improves manic symptoms and assess its safety.
Medication studyAges 18–65Multiple countries
Understand this study
What is this study about?
Researchers compare KarXT with placebo, each added to lithium, valproate or lamotrigine, in people with bipolarity type I experiencing mania, with or without mixed features. They want to know whether adding KarXT improves manic symptoms and assess its safety.
Who could participate?
Listed age limits: 18 years to 65 years.
- Listed locations
- Bentonville, United States · Little Rock, United States and 89 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
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
Show the full 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
Recruitment & locations
RecruitingBentonville, United States · Little Rock, United States · Bellflower, United States
88 more locations
- Chino, United States
- Culver City, United States
- La Habra, United States
- Montclair, United States
- Orange, United States
- Riverside, United States
- Hallandale, United States
- Miami, United States
- West Palm Beach, United States
- Savannah, United States
- Chicago, United States
- St Louis, United States
- Staten Island, United States
- Austin, United States
- Houston, United States
- Mansfield, United States
- Richardson, United States
- ABB, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Santiago del Estero, Argentina
- Kazanlak, Bulgaria
- Novi Iskar, Bulgaria
- Pleven, Bulgaria
- Sliven, Bulgaria
- Targovishte, Bulgaria
- Beijing, China
- Guangzhou, China
- Baoding, China
- Shijiazhuang, China
- Nanjing, China
- Xi'an, China
- Chengdu, China
- Tianjin, China
- Ningbo, China
- Changsha, China
- Hillerød, Denmark
- Aalborg, Denmark
- Glostrup Municipality, Denmark
- Nice, France
- Clermont-Ferrand, France
- Marseille, France
- Montpellier, France
- Paris, France
- Mangalore, India
- Madurai, India
- Kolkata, India
- Hod HaSharon, Israel
- Ramat Gan, Israel
- Ashkelon, Israel
- Beersheba, Israel
- Jerusalem, Israel
- Milan, Italy
- Pisa, Italy
- Siena, Italy
- Ancona, Italy
- Genova, Italy
- Toyoake, Japan
- Ichikawa, Japan
- Iizuka, Japan
- Kitakyushu-shi, Japan
- Sapporo, Japan
- Yokohama, Japan
- Karatsu, Japan
- Bunkyo-ku, Japan
- Kodaira, Japan
- tabashi City, Japan
- Fukuoka, Japan
- Kochi, Japan
- Warsaw, Poland
- Gdansk, Poland
- Rybnik, Poland
- Tuszyn, Poland
- Bucharest, Romania
- Iași, Romania
- Sanpetru /Brasov, Romania
- Sibiu, Romania
- Smila, Ukraine
- Dnipro, Ukraine
- Skarzhyntsi, Ukraine
- Nove, Ukraine
- Hlevakha, Ukraine
- Kyiv, Ukraine
- Lviv, Ukraine
- Odesa, Ukraine
- Vinnytsia, Ukraine
- Poltava, Ukraine
- Ternopil, Ukraine
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers compare KarXT with placebo, each added to lithium, valproate or lamotrigine, in people with bipolarity type I experiencing mania, with or without mixed features. They want to know whether adding KarXT improves manic symptoms and assess its safety.
Who is behind this study?
The study sponsor is Bristol-Myers Squibb, a pharmaceutical company.
Does this study involve medication?
Yes. The study involves medication, including Xanomeline/Trospium Chloride and Placebo.
Who can participate?
Listed age limits: 18 years to 65 years.
Is this study still recruiting?
The registry lists this study as recruiting.
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