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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II

In brief

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

Key facts

Study ID

NCT05025605

Run by

BioXcel Therapeutics Inc

People needed

140

Starts

2021-08-27

Expected to finish

2027-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 are judged to be at significant risk of suicide.
• Patients with serious or unstable medical illnesses.
• 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.

Where it is running

• BioXcel Clinical Research Site — Anaheim, California, United States (enrolling)
• Bioxcel Clinical Research Site — Hialeah, Florida, United States (enrolling)
• Bioxcel Clinical Research Site — Decatur, Georgia, United States (enrolling)
• BioXcel Clinical Research Site — DeSoto, Texas, United States (enrolling)
• BioXcel Clinical Research Site — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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