Tests BXCL501 for agitation in children with schizophrenia or bipolar disorder
Tests BXCL501 against a placebo for agitation in children with schizophrenia or bipolar disorder.
Plain-language title generated from the registry record
Registry title: Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Key facts
- Where
- Anaheim, Atlanta, Decatur, DeSoto, and Hialeah, United StatesSee the 5 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT05025605, who can take part
Where in United States
- AnaheimAnaheim, United StatesTaking people
- AtlantaAtlanta, United StatesNo longer taking part
- DecaturDecatur, United StatesTaking people
- DeSotoDeSoto, United StatesTaking people
- HialeahHialeah, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioXcel Therapeutics Inc
- Trial code
- NCT05025605
- Record updated
- 11 August 2026
- Original description
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Study to Determine 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.
Inclusion: Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria); Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC); Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline; Participants who agree to use a medically acceptable and effective birth control method.
Exclusion: Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening; Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment; Patients who have received an investigational drug within 30 days prior to the current agitation episode; Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug; Patients with serious or unstable medical illnesses; Patients who are judged to be at significant risk of suicide.