Recruiting

Sublingual Dexmedetomidine

Sponsor:

Temple University

Code:

NCT06093451

Conditions

Schizophrenia Agitation

Schizo Affective Disorder

Bipolar Disorder

Dexmedetomidine

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Lorazepam 2 MG/ML

Study Details

Brief summary:

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

Study ID

NCT06093451

Start date

Jul 1, 2023

Status verified date

Oct, 2023

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Dexmedetomidine

Moderate agitation: 120 mcg Severe agitation: 180 mcg

Lorazepam 2 MG/ML

2 mg

Primary outcome measure

  • Change in PANSS-EC score at 120 minutes after medication administration [ Time Frame: Baseline and at 120 minutes ]

Central Contacts and Locations

Central contacts

Justin Faden, DO

2157070401Justin.Faden@tuhs.temple.edu

Meghan Musselman, MD

2157078483Meghan.Musselman@tuhs.temple.edu

Locations

Temple University Episcopal Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19125

More Information

Sponsor

Temple University

Last update posted

Oct 23, 2023

Last verified

Oct, 2023

Keywords

  • Agitation
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2023-10-23.