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

Testing BXCL501's safety and effectiveness for kids with schizophrenia and bipolar disorder.

Recruiting
10-17 years
All
Phase 1

This study is testing a new medicine, **BXCL501**, to see if it helps calm kids and teens with **schizophrenia** or **bipolar disorder** who are feeling very upset. Schizophrenia affects how a person thinks, feels, and behaves, while bipolar disorder causes extreme mood swings. The study will have about 140 participants who will receive either BXCL501 or a **placebo** (a fake pill with no medicine) in different doses. Everyone in the study will stay in a hospital or research center to make sure they are safe and to check if the medicine works.

To join, participants must be between 10 and 17 years old, have bipolar disorder or schizophrenia, and be very agitated. They must also agree to use birth control. People who are not allowed to join include those who are intoxicated, have taken certain medicines recently, are very sick, or are at risk of harming themselves.

  • Study includes hospital stay for safety checks.
  • Participants must be between 10-17 years old with specific conditions.
  • Excludes recent drug trials and certain medical conditions.
Study details
    Schizophrenia
    Schizo-Affective Disorder
    Schizophreniform; Schizophrenic
    Bipolar Disorder I
    Bipolar Disorder II

NCT05025605

BioXcel Therapeutics Inc

24 November 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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