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RecruitingNCT06951711

KarXT for manic episodes in bipolarity type I

This study is recruiting in the United States, in Croatia, in India, .... It is testing KarXT for manic episodes in bipolarity type I.

BipolarityDrugFrom 18 Years to 65 Years
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Study ID: NCT06951711. We help you review the study, but cannot decide medical eligibility.
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, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Croatia, India, Israel.

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.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including Pillar Clinical Research- Little Rock, Woodland Research Northwest in Rogers, and Proscience Research Group in Culver City. 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.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: June 13, 2025
Recruitment status
Recruiting
Estimated enrollment
Not clearly listed
Sponsor
Bristol-Myers Squibb
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug, OTHER
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Croatia, India, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT06951711
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-2)
Official source
Official registry link

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Study ID: NCT06951711. We help you review the study, but cannot decide medical eligibility.
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 Croatia.

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, Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

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 registry indicates that this study is currently recruiting. This does not mean you are eligible: the study team must confirm the criteria, available locations, and next steps.

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KarXT for manic episodes in bipolarity type I — Bipolarity Clinical Trial | HopeStage