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NCT05025605 · ClinicalTrials.gov registry record · Phase 1
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
A Phase 1 study of Schizophrenia and Schizoaffective Disorder, sponsored by BioXcel Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 5
- Study locations
NCT05025605: Recruiting Phase 1 study of Schizophrenia and Schizoaffective Disorder, sponsored by BioXcel Therapeutics.
NCT05025605 is a Phase 1 study of Schizophrenia and Schizoaffective Disorder that is actively recruiting participants, run by BioXcel Therapeutics. The registered enrollment target is 140 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (36% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05025605, a Phase 1 study of Schizophrenia and Schizoaffective Disorder, is actively recruiting participants, sponsored by BioXcel Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
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 |
What NCT05025605 shows while recruiting
NCT05025605 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (36% lower).
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.
NCT05025605 lists 5 locations in 4 states (Georgia, California, Florida).
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, Schizoaffective Disorder, Bipolar Disorder I, Bipolar Disorder II, Schizophreniform; Schizophrenic.
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).
Who is sponsoring clinical trial NCT05025605?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05025605's enrollment target sits among peer trials
140 111th of 315 higher than 203 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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