RECRUITING

Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or 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

An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

Official Title

An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Quick Facts

Study Start:2023-07-01
Study Completion:2024-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06093451

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 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant is an adult between the ages of 18-55 at the time of study participation
  2. * Hospitalized on an inpatient unit at Episcopal Hospital
  3. * Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.
  4. * Are able to understand and read English
  5. * Are able to provide informed consent
  6. * Experiencing a moderate (PANSS-EC score ≥14 and \<20) or severe (PANSS-EC score ≥20) episode of agitation
  1. * Women who are pregnant or breastfeeding
  2. * Prisoners
  3. * Participant has an allergy to dexmedetomidine or lorazepam
  4. * Participant has mild, moderate or severe hepatic impairment
  5. * Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)
  6. * Individual is currently prescribed scheduled benzodiazepines or methadone
  7. * Participant history of QTc ≥ 500 msec or a history of arrythmia
  8. * Participant recent (within the last 2 days) fall, syncope (passing out), feeling lightheaded, or pulse \<50.
  9. * Individual has a history of hypokalemia or hypomagnesemia within the past 2 years?
  10. * Participant is receiving high-risk medications, including:
  11. 1. Methadone
  12. 2. Midazolam
  13. 3. Opioids
  14. 4. High risk medications associated with the QT interval prolongation (sertindole, chlorpromazine, ziprasidone), (amiodarone, iboga, quinine, arsenic, ibutilide, selpercatinib, ivosidenib, bedaquiline, lenvatinib, sotalol, levoketoconazole, cisapride, vendetanib, mobocertinib, disopyramide, papaverine)

Contacts and Locations

Study Contact

Justin Faden, DO
CONTACT
2157070401
Justin.Faden@tuhs.temple.edu
Meghan Musselman, MD
CONTACT
2157078483
Meghan.Musselman@tuhs.temple.edu

Study Locations (Sites)

Temple University Episcopal Hospital
Philadelphia, Pennsylvania, 19125
United States

Collaborators and Investigators

Sponsor: Temple 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 Date2023-07-01
Study Completion Date2024-07-01

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2024-07-01

Terms related to this study

Keywords Provided by Researchers

  • Agitation
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder

Additional Relevant MeSH Terms

  • Schizophrenia Agitation
  • Schizo Affective Disorder
  • Bipolar Disorder
  • Dexmedetomidine