Last updated: October 16, 2023
Sponsor: Temple University
Overall Status: Active - Recruiting
Phase
4
Condition
Bipolar Disorder
Psychosis
Affective Disorders
Treatment
Lorazepam 2 MG/ML
Dexmedetomidine
Clinical Study ID
NCT06093451
30561
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The participant is an adult between the ages of 18-55 at the time of studyparticipation
- Hospitalized on an inpatient unit at Episcopal Hospital
- Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolardisorder, 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
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), feelinglightheaded, 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)
Study Design
Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Lorazepam 2 MG/ML
Phase: 4
Study Start date:
July 01, 2023
Estimated Completion Date:
July 01, 2024
Study Description
Connect with a study center
Temple University Episcopal Hospital
Philadelphia, Pennsylvania 19125
United StatesActive - Recruiting
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