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

This trial tests a medication called BXCL501 — a sedative given under the tongue — to calm agitation in children and teenagers who have bipolar disorder or schizophrenia. It aims to provide a gentler, faster-acting alternative to injections for acute episodes of severe restlessness or agitation. **You may be eligible if...** - You are between 10–17 years old with bipolar disorder, or 13–17 years old with schizophrenia - You are currently experiencing significant agitation (as measured by a clinical scale) - You agree to use birth control if applicable **You may NOT be eligible if...** - Your agitation is caused by alcohol or drug intoxication - You have taken sedatives, sleep aids, or short-acting antipsychotic injections in the last 4 hours - You are considered at significant risk of suicide - You have a serious unstable medical illness - You have taken an experimental drug in the past 30 days Talk to your doctor to see if this trial is right for you.