Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

This study looks at how well and safely a medicine called BXCL501 works for children and teens who feel very upset because of bipolar disorder or schizophrenia. **Bipolar disorder** is when someone has extreme mood swings. **Schizophrenia** is a serious brain disorder that makes it hard to think clearly. The study will include about 140 kids who are upset and in the hospital. They are divided into groups to get different doses of the medicine or a fake pill (placebo). The kids need to stay in the hospital so doctors can watch them closely. The study checks if the medicine helps calm the kids down safely.

• The study includes kids ages 10-17 with bipolar disorder, and 13-17 with schizophrenia.
• It requires hospital stays to monitor health and reactions to the medicine.
• The children will be checked before and after taking the medicine to see if it works and is safe.