RECRUITING

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

Talk to us

Conditions

SchizophreniaSchizo-Affective DisorderSchizophreniform; SchizophrenicBipolar Disorder IBipolar Disorder II

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-08-27
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05025605

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.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
  4. 4. Participants who agree to use a medically acceptable and effective birth control method
  1. 1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
  2. 2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
  3. 3. Patients who are judged to be at significant risk of suicide.
  4. 4. Patients with serious or unstable medical illnesses.
  5. 5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.
  6. 6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

Contacts and Locations

Study Contact

Regan Dickinson
CONTACT
475-228-2920
rdickinson@bioxceltherapeutics.com
Carl Gommoll
CONTACT
475-355-5177
cgommoll@bioxceltherapeutics.com

Principal Investigator

Robert Risinger, MD
STUDY_CHAIR
BioXcel Therapeutics

Study Locations (Sites)

BioXcel Clinical Research Site
Anaheim, California, 92805
United States
Bioxcel Clinical Research Site
Hialeah, Florida, 33016
United States
BioXcel Clinical Research Site
Atlanta, Georgia, 30331
United States
Bioxcel Clinical Research Site
Decatur, Georgia, 30030
United States
BioXcel Clinical Research Site
DeSoto, Texas, 75115
United States

Collaborators and Investigators

Sponsor: BioXcel Therapeutics Inc

  • Robert Risinger, MD, STUDY_CHAIR, BioXcel Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-27
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-08-27
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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