Testing BXCL501 for agitation in children with schizophrenia and bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: BioXcel CTM
• Email: info@bioxceltherapeutics.com
• Phone: 475-238-6837

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.