Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06093451
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06093451
Study Brief:
Protocol Section:
NCT06093451