Using sublingual dexmedetomidine to treat agitation in patients with schizophrenia or bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized control trial evaluates the efficacy and tolerability of sublingual dexmedetomidine compared to oral lorazepam for treating agitation in hospitalized patients with schizophrenia or bipolar disorder. A total of 32 participants will be randomized to receive either dexmedetomidine or lorazepam based on their level of agitation, as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and the Agitation-Calmness Evaluation Scale (ACES). The study will assess outcomes at multiple time points to determine the effectiveness of the treatment.

Why it matters

Who can join: the full rules

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)

Where it's running

• Temple University Episcopal Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Justin Faden, DO
• Email: Justin.Faden@tuhs.temple.edu
• Phone: 2157070401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.