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RecruitingNCT05025605

BXCL501 for schizophrenia

This study is recruiting in the United States. It is testing BXCL501 for schizophrenia.

Bipolarity, Schizophrenia, ...DrugFrom 10 Years to 17 Years
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Study ID: NCT05025605. 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 BXCL501 may be useful for adolescents experiencing bipolarity.

What would participation involve?

Participants may receive BXCL501, 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 United States.

Who is it mainly for?

This study appears to be mainly for adolescents with bipolarity. Because it involves minors, a parent or guardian may need to be involved.

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, what role parents or guardians have in the process.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including BioXcel Clinical Research Site in Anaheim, Bioxcel Clinical Research Site in Hialeah, and BioXcel Clinical Research Site in Atlanta. Participation appears to involve guided sessions or support activities with check-ins on how they fit into daily life. The main fit is usually meeting the main study requirements, while common reasons not to take part include active substance or alcohol problems that could affect the results. This is an early-stage study, which usually means a smaller group and a focus on learning how the approach behaves.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: August 27, 2021
Recruitment status
Recruiting
Estimated enrollment
Not clearly listed
Sponsor
BioXcel Therapeutics Inc
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
Locations
United States
Age range
From 10 Years to 17 Years
Official registry ID
NCT05025605
Official title
A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Official source
Official registry link

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Study ID: NCT05025605. 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 follow-up, often through questionnaires or interviews.

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

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. It includes a comparison with placebo. 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 BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms. Phase 1 studies usually focus mainly on safety, tolerability, dosage, and side effects. They often involve healthy volunteers, but not always. Some Phase 1 studies include people living with the target condition.

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 BioXcel Therapeutics Inc, which appears to be a biotech company. The listed contact or investigator is BioXcel Therapeutics Inc, affiliated with BioXcel Therapeutics Inc. 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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