Testing a fast-acting medication for severe agitation in teens with schizophrenia or bipolar disorder

This trial is testing a medication called BXCL501 to see if it can quickly calm severe agitation in children and teenagers who have been diagnosed with schizophrenia or bipolar disorder. The medication comes as a thin film that dissolves under the tongue. Researchers want to find out if this treatment is both safe and effective for young people experiencing a crisis moment of severe agitation.

When children and teens with schizophrenia or bipolar disorder become severely agitated, they need fast help to stay safe—but current options don't always work quickly enough or as well as doctors would like. This study aims to find out whether this new treatment can help calm agitation faster and more effectively.