COMPLETED

BXCL501 for Agitation in Schizophrenia

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

Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.

Official Title

Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia

Quick Facts

Study Start:2020-03-09
Study Completion:2023-05-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03708315

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability to give informed consent.
  2. 2. Male or female between 18 and 65 years of age, inclusive
  3. 3. According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.
  1. 1. Current significant medical condition or other comorbidities
  2. 2. Current substance dependence
  3. 3. Women who are pregnant or breastfeeding

Contacts and Locations

Principal Investigator

Mohini Ranganathan, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Connecticut Mental Health Center
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

  • Mohini Ranganathan, MD, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2020-03-09
Study Completion Date2023-05-26

Study Record Updates

Study Start Date2020-03-09
Study Completion Date2023-05-26

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder