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

Prior treatment

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

Other illness

• Patients with serious or unstable medical illnesses.

Other

• Patients who are judged to be at significant risk of suicide.

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