Actively Recruiting
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Led by BioXcel Therapeutics Inc · Updated on 2026-04-13
140
Participants Needed
5
Research Sites
331 weeks
Total Duration
On this page
Sponsors
B
BioXcel Therapeutics Inc
Lead Sponsor
P
ProPharma Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects between 10 and 17 years old with bipolar disorder (DSM-5 criteria)
- Subjects between 13 and 17 years old with schizophrenia (DSM-5 criteria)
- Clinically agitated patients with a total score of 14 or higher on the PANSS Excited Component (PEC) at screening and baseline
- Patients with a score of 4 or higher on at least one of the five PEC items at baseline
- Participants agreeing to use a medically acceptable and effective birth control method
You will not qualify if you...
- Agitation caused by acute intoxication, including alcohol or drugs of abuse (except THC) during urine screening
- Use of benzodiazepines, hypnotics, or short-acting intramuscular antipsychotics within 4 hours before study treatment
- Patients judged to be at significant risk of suicide
- Patients with serious or unstable medical illnesses
- Receipt of an investigational drug within 30 days before current agitation episode
- Patients considered unsuitable for study drug by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
BioXcel Clinical Research Site
Anaheim, California, United States, 92805
Actively Recruiting
2
Bioxcel Clinical Research Site
Hialeah, Florida, United States, 33016
Actively Recruiting
3
BioXcel Clinical Research Site
Atlanta, Georgia, United States, 30331
Completed
4
Bioxcel Clinical Research Site
Decatur, Georgia, United States, 30030
Actively Recruiting
5
BioXcel Clinical Research Site
DeSoto, Texas, United States, 75115
Actively Recruiting
Research Team
B
BioXcel CTM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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