Using sublingual dexmedetomidine to treat agitation in patients with schizophrenia or bipolar disorder
An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
PHASE4 · Temple University · NCT06093451
This study is testing whether a new under-the-tongue medication called dexmedetomidine can help reduce agitation in hospitalized patients with schizophrenia or bipolar disorder better than the standard treatment, lorazepam.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Temple University (other) |
| Drugs / interventions | selpercatinib, lenvatinib, mobocertinib |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06093451 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 who are hospitalized and experiencing moderate to severe agitation due to schizophrenia or bipolar disorder.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as severe hepatic impairment or active pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing agitation in patients with schizophrenia or bipolar disorder.
How similar studies have performed: While the use of dexmedetomidine for agitation is being explored, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Philadelphia, Pennsylvania
- Temple University Episcopal Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Justin Faden, DO
- Email: Justin.Faden@tuhs.temple.edu
- Phone: 2157070401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine, Agitation, Schizophrenia, Schizoaffective Disorder