ACTIVE_NOT_RECRUITING

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

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 open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and correlate them with clinician-assessed ratings.

Official Title

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

Quick Facts

Study Start:2025-06-19
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07116694

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:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Matt Mandel, MD
STUDY_CHAIR
BioXcel Therapeutics

Study Locations (Sites)

BioXcel Clinical Research Site 103
Chino, California, 91710
United States
BioXcel Clinical Research Site 105
Oceanside, California, 92056
United States
BioXcel Clinical Research Site 102
Orange, California, 92868
United States
BioXcel Clinical Research Site 101
St Louis, Missouri, 63125
United States
BioXcel Clinical Research Site 106
Las Vegas, Nevada, 89119
United States

Collaborators and Investigators

Sponsor: BioXcel Therapeutics Inc

  • Matt Mandel, 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 Date2025-06-19
Study Completion Date2025-10

Study Record Updates

Study Start Date2025-06-19
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar I Disorder
  • Bipolar II Disorder
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorders
  • Psychomotor Agitation