Testing BXCL501 for agitation in children with schizophrenia and bipolar disorder

A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

This study is testing if a new medication called BXCL501 can help reduce agitation in children and teens aged 10-17 with bipolar disorder or schizophrenia.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 10 Years to 17 Years
• Sex: All
• Sponsor: BioXcel Therapeutics Inc (Industry-sponsored)
• Locations: 5 sites (Anaheim, California and 4 other locations)
• Trial ID: NCT05025605 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of BXCL501 in treating acute agitation in children and adolescents aged 10-17 with bipolar disorder or schizophrenia. Approximately 140 participants will be randomized to receive either BXCL501 at different dosages or a placebo. The study will take place in a clinical research setting or hospital, where subjects will be monitored for their agitation levels and overall health. Efficacy and safety assessments will be conducted periodically throughout the study.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 10-17 with a diagnosis of bipolar disorder or schizophrenia who are experiencing acute agitation.

Not a fit: Patients whose agitation is due to substance intoxication or those at significant risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing acute agitation in pediatric patients with serious mental health conditions.

How similar studies have performed: While this approach is novel in the pediatric population, similar studies in adults have shown promising results with BXCL501.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. 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).
3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
4. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
3. Patients who are judged to be at significant risk of suicide.
4. Patients with serious or unstable medical illnesses.
5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.
6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

Where this trial is running

Anaheim, California and 4 other locations

• BioXcel Clinical Research Site — Anaheim, California, United States (Recruiting)
• Bioxcel Clinical Research Site — Hialeah, Florida, United States (Recruiting)
• BioXcel Clinical Research Site — Atlanta, Georgia, United States (Completed)
• Bioxcel Clinical Research Site — Decatur, Georgia, United States (Recruiting)
• BioXcel Clinical Research Site — DeSoto, Texas, United States (Recruiting)

Study contacts

• Study coordinator: BioXcel CTM

Conditions Schizophrenia; Schizo-Affective Disorder; Schizophreniform; Schizophrenic; Bipolar Disorder I; Bipolar Disorder II