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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Anaheim

BioXcel Clinical Research Site, Anaheim, California, United States, 92805

Hialeah

Bioxcel Clinical Research Site, Hialeah, Florida, United States, 33016

Atlanta

BioXcel Clinical Research Site, Atlanta, Georgia, United States, 30331

Decatur

Bioxcel Clinical Research Site, Decatur, Georgia, United States, 30030

DeSoto

BioXcel Clinical Research Site, DeSoto, Texas, United States, 75115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioXcel Therapeutics Inc,

Robert Risinger, MD, STUDY_CHAIR, BioXcel Therapeutics

Study Record Dates

2026-12-31