Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Purpose
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.
Conditions
- Schizophrenia Agitation
- Schizo Affective Disorder
- Bipolar Disorder
- Dexmedetomidine
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dexmedetomidine |
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed. |
|
|
Active Comparator Lorazapem |
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Temple University
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 for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and <20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes.
