Status:
UNKNOWN
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Lead Sponsor:
Temple University
Collaborating Sponsors:
BioXcel Therapeutics Inc
Conditions:
Schizophrenia Agitation
Schizo Affective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 bip...
Detailed Description
This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy f...
Eligibility Criteria
Inclusion
- 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
- 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:
- Methadone
- Midazolam
- Opioids
- 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)
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06093451
Start Date
July 1 2023
End Date
July 1 2024
Last Update
October 23 2023
Active Locations (1)
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1
Temple University Episcopal Hospital
Philadelphia, Pennsylvania, United States, 19125