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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborator: BioXcel Therapeutics Inc
• Treatments: Dexmedetomidine; Lorazepam

Criteria

Inclusion Criteria:

• The participant is an adult between the ages of 18-55 at the time of study participation

• Hospitalized on an inpatient unit at Episcopal Hospital

• Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.

• Are able to understand and read English

• Are able to provide informed consent

• Experiencing a moderate (PANSS-EC score ≥14 and <20) or severe (PANSS-EC score ≥20) episode of agitation

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Prisoners

• Participant has an allergy to dexmedetomidine or lorazepam

• Participant has mild, moderate or severe hepatic impairment

• Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)

• Individual is currently prescribed scheduled benzodiazepines or methadone

• Participant history of QTc ≥ 500 msec or a history of arrythmia

• Participant recent (within the last 2 days) fall, syncope (passing out), feeling lightheaded, or pulse <50.

• Individual has a history of hypokalemia or hypomagnesemia within the past 2 years?

• Participant is receiving high-risk medications, including:

1. Methadone

2. Midazolam

3. Opioids

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)