RecruitingPhase 1Mentions an overnight / inpatient stay

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

BioXcel Therapeutics Inc · with ProPharma Group · NCT05025605

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

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

Being studied: BXCL501 80 Micrograms; Placebo Film; BXCL501 120 Micrograms; BXCL501 60 Micrograms

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

Copied from the official record. The study team makes the final decision at screening.

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Inclusion Criteria

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

Exclusion Criteria

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.

BioXcel Clinical Research Site
Anaheim, CA 92805
Site contact: BioXcel CTM · 475-254-5899 · info@bioxceltherapeutics.com
Bioxcel Clinical Research Site
Hialeah, FL 33016
Site contact: Bioxcel CTM · 475-254-5899 · info@bioxceltherapeutics.com
Bioxcel Clinical Research Site
Decatur, GA 30030
Site contact: Bioxcel CTM · 475-254-5899 · info@bioxceltherapeutics.com
BioXcel Clinical Research Site
DeSoto, TX 75115
Site contact: Bioxcel CTM · 475-254-5899 · info@bioxceltherapeutics.com