Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Temple University

Status and phase: Enrolling; Phase 4

Conditions: Dexmedetomidine; Bipolar Disorder; Schizo Affective Disorder; Schizophrenia Agitation

Treatments: Drug: Lorazepam 2 MG/ML; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06093451

30561

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Dexmedetomidine

Experimental group

Description:

Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.

Treatment:

Drug: Dexmedetomidine

Lorazapem

Active Comparator group

Description:

Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.

Treatment:

Drug: Lorazepam 2 MG/ML