Back to all studies
RecruitingNCT06951698

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of manic episodes in Bipolarity type I

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States, Argentina, Australia, Bulgaria, Hungary, Japan, New Zealand, and Poland.

BipolarityDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

This study is looking at evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolarity type I for people with Bipolarity type I with mania or mania with mixed features. Participants are followed over time so researchers can learn from clinical and follow-up information. This study may not offer a new treatment, and its main value is helping researchers learn from follow-up information that may improve future care.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including Pillar Clinical Research - Bentonville, Woodland International Research Group in Little Rock, and Advanced Research Center Inc in Anaheim. 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. 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 KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
Condition
Bipolar-I Disorder With Mania or Mania With Mixed Features
Study status
Recruiting
Phase
Phase 3
Sponsor / lead affiliation
Bristol-Myers Squibb
Intervention
KarXT, Placebo
Location / country
United States, Argentina, Australia, Bulgaria, Hungary, Japan, New Zealand, Poland
Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, First line of the email MUST contain NCT # and Site #., Fayz Hudefi, Site 0058, George Konis, Site 0011, Steven Macina, Site 0005, Robert Bota, Site 0008, Site 0014, David Walling, Site 0059, Stephen Volk, Site 0072, Tony Ortiz, Site 0053, Deepak D'Souza, Site 0124, Edwin Gomez, Site 0043, Moraima Trujillo, Site 0020, Silvia Silva Duluc, Site 0069, Rishi Kakar, Site 0054, Site 0015, Mohammad Nisar, Site 0023, Bethany Davis, Site 0009, Michael Mobley, Site 0057, Roueen Rafeyan, Site 0047, Peter Weiden, Site 0030, Shishuka Malhotra, Site 0013, Scott Bartley, Site 0044, José Faccioli, Site 0110, Carlos Morra, Site 0115, Site 0108, Site 0109, Philip Mitchell, Site 0117, James Scott, Site 0106, Veselin Palazov, Site 0113, Tsveteslava Galabova, Site 0119, Maya Stoimenova - Popova, Site 0112, Rozalina Petrova, Site 0120, Nadya Ivanova, Site 0121, Gabor Feller, Site 0116, Site 0114, János Réthelyi, Site 0118, Takakura Masashi, Site 0082, kiyoshi Fujita, Site 0079, Toshihiko Ito, Site 0078, Kengo Furuse, Site 0090, Kimihiro Nakajima, Site 0080, Masaki Kato, Site 0089, Taro Shindo, Site 0087, Narifumi Yokoyama, Site 0092, Takamasa Noda, Site 0105, Yuya Tenjin, Site 0085, Noriko Tamaru, Site 0083, Jiro Kawano, Site 0077, Yasuhiko Deguchi, Site 0086, Site 0084, Kenji Sanada, Site 0104, Sohei Kimoto, Site 0076, Nobuhiro Yokokawa, Site 0088, Sylvester Miles, Site 0055, Sylwia Szymkowiak, Site 0095, Adam Wichniak, Site 0107, Napoleon Waszkiewicz, Site 0094, Site 0111, Wojciech Eysymontt, Site 0103, Site 0102, Jaroslaw Strzelec, Site 0096
Email
Clinical.Trials@bms.com
Phone
855-907-3286, 479-367-2688, 501-221-8681, 714-999-6688, 562-748-4999, 714-799-7799, 909-590-8409, 714-289-1100, 20393257112594, 954-604-3900, 305-246-0001, 305-669-6166, 786-512-4106, 786-831-7303, 404-255-6005, 912-744-0800, 312-865-6336, 917-701-7484, 330-493-1118, 214-396-4844, +5491157934078, 5493516858696, +61 2 9433 3555, +61 1300 290 645, 359888451225, 359892444643, +359888227165, 00359887801545, +359887422440, +3612100336, +81587557251, 0562971361, +81-47-372-3501, 81155650102, +81-11-771-5660, +81-6-6992-1001, 0955770711, 048-536-1366, +81-42-341-2711, 0339391191, +81-92-811-1821, 81985244181, +81-6-6645-3821, +81-3-3300-5231, 073-441-0659, +81236312315, +6421963555, +48604116632, +48600-107-410, +48608888796, +48609673001, 602305132
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating KarXT, 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.

Loading the security check...
Study reference: NCT06951698. 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
KarXT, 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 KarXT for the Treatment of manic episodes in Bipolarity type I?

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.

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