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RecruitingNCT05025605

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolarity

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States.

BipolarityDrugFrom 10 Years to 17 Years
In plain English

Key information made simple

This study is comparing BXCL501 80 Micrograms with placebo for people with psychosis or bipolarity. Participants receive BXCL501 80 Micrograms or placebo and complete study visits and assessments. Some participants may receive placebo instead of the study treatment, and direct benefit is not guaranteed.

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.

Public study data

Key study information

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
Condition
Schizophrenia; Schizo-Affective Disorder; Schizophreniform; Schizophrenic; Bipolar Disorder I; Bipolar Disorder II
Study status
Recruiting
Phase
Phase 1
Sponsor / lead affiliation
BioXcel Therapeutics Inc
Intervention
BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Location / country
United States
Contact
BioXcel CTM
Email
info@bioxceltherapeutics.com
Phone
475-238-6837, 475-254-5899
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms 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.

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Study reference: NCT05025605. 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 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

Study clarity

Things to check before joining

Sponsor
BioXcel Therapeutics Inc
Sponsor type
Biotech company
Main activity
medication or study treatment
Intervention
BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Time commitment
multiple visits or assessments
Study phase
Phase 1
Enrollment
Not available
Recruitment status
Recruiting
Source
Official registry link
FAQ

Questions about this study

What is Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolarity?

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.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by BioXcel Therapeutics Inc. Based on the sponsor name or official registry information, it appears to be a biotech company. You should verify the details 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 multiple visits or assessments. The study phase is Phase 1. 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.

Determining Efficacy and Safety of BXCL501 in. — Bipolarity Clinical Trial | HopeStage