KarXT for manic episodes in bipolarity type I
This study is recruiting in the United States, in Australia, in New Zealand, .... It is testing KarXT for manic episodes in bipolarity type I.
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 Argentina, Australia, 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 placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.
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.
Questions to ask before joining
- What are the exact eligibility criteria, and what could exclude someone?
- How many visits, assessments, or follow-ups are expected, and over what period?
- What risks, side effects, practical burdens, or alternatives should be understood first?
- Who should be contacted to confirm locations, timing, compensation, and next steps?
Things to check before joining
- 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, Australia, New Zealand, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT06951698
- 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)
- Official source
- Official registry link
Want help reviewing this study?
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 Argentina.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
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.
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 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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