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RecruitingPhase 1

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

A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well BXCL501 works and how safe it is for children and teens with acute agitation, or strong restlessness or distress. It is for those ages 10–17 with bipolar disorder or ages 13–17 with schizophrenia.

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have bipolar disorder and be age 10–17, or have schizophrenia and be age 13–17, based on standard diagnosis rules.
  • Have agitation at both screening and the starting visit, with a total score of at least 14 on a five-part agitation rating scale.
  • Score at least 4 on one or more parts of that scale at the starting visit.
  • Agree to use an effective birth control method accepted by the study team.

Who can't join

  • Have agitation caused by recent alcohol or drug use found during urine screening, except THC, a substance in cannabis.
  • Have taken certain calming or sleep medicines, or antipsychotic medicines by mouth or short-acting muscle injection, within 4 hours before study treatment.
  • Be judged to have a high risk of suicide.
  • Have a serious medical illness or one that is not stable.
  • Have received an experimental drug within 30 days before the current agitation episode.
  • Be judged by the study doctor to be unable to safely or suitably receive the study drug for any reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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). 2. 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). 3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline. 4. Participants who agree to use a medically acceptable and effective birth control method Exclusion Criteria: 1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening. 2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment. 3. Patients who are judged to be at significant risk of suicide. 4. Patients with serious or unstable medical illnesses. 5. Patients who have received an investigational drug within 30 days prior to the current agitation episode. 6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

Study sites (5)

CA

FL

GA

TX