BXCL501 for Agitation in Pediatric Schizophrenia and Bipolar Disorder
This study is looking at how well and how safely BXCL501 works to calm agitation (feeling restless or upset) in children and teenagers. Participants will receive either BXCL501 (at doses of 60, 80, or 120 micrograms) or a placebo (an inactive film that looks the same) as a film placed under the tongue. You could be eligible if you are between 10 and 17 years old with bipolar disorder, or 13 and 17 years old with schizophrenia or schizo-affective disorder, and are experiencing agitation. The main goal is to see how much agitation improves after 120 minutes. The study is currently unclear on its recruitment status and plans to enroll about 140 participants.
- Study design
- This is an interventional study that will include approximately 140 participants. Participants will be randomly assigned to receive different doses of BXCL501 or a placebo.
- What's involved
- You would be admitted to a clinical research setting or hospital for screening and medical supervision. Efficacy and safety assessments will be done before and after receiving the study treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main measurement of improvement is taken 120 minutes after receiving the study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- BioXcel MM, MD · STUDY_CHAIR · BioXcel Therapeutics
Who to contact
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What this trial measures
- Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score120 minutes - Group one only
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)