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Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
NCT05025605 · View on ClinicalTrials.gov ↗
Study Summary
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Conditions Studied
Interventions
- DRUG BXCL501 80 Micrograms
- DRUG Placebo Film
- DRUG BXCL501 120 Micrograms
- DRUG BXCL501 60 Micrograms
Study Locations (5)
Georgia
- BioXcel Clinical Research Site — Atlanta
- Bioxcel Clinical Research Site — Decatur
California
- BioXcel Clinical Research Site — Anaheim
Florida
- Bioxcel Clinical Research Site — Hialeah
Texas
- BioXcel Clinical Research Site — DeSoto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05025605
The ClinicalTrials.gov registry entry for NCT05025605 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioXcel Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions — of which BXCL501 80 Micrograms is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05025605 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Georgia, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05025605 about?
NCT05025605 is a clinical study titled "Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder". This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
What is the current status of trial NCT05025605?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2021-08-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05025605 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar Disorder I, Bipolar Disorder II, Schizo-Affective Disorder, Schizophreniform; Schizophrenic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05025605?
The interventions under investigation include: BXCL501 80 Micrograms (DRUG), Placebo Film (DRUG), BXCL501 120 Micrograms (DRUG), BXCL501 60 Micrograms (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05025605?
This trial is sponsored by BioXcel Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05025605 being conducted?
This trial has 5 study locations across California, Florida, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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