Bipolar Disorder, Dexmedetomidine, Schizo Affective Disorder, Schizophrenia Agitation
Conditions
Keywords
Agitation, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
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.
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.
Interventions
DRUGDexmedetomidine
Moderate agitation: 120 mcg Severe agitation: 180 mcg
DRUGLorazepam 2 MG/ML
2 mg
Sponsors
BioXcel Therapeutics Inc
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PANSS-EC score at 120 minutes after medication administration | Baseline and at 120 minutes | Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score \>=14 and \<20; and \>= 20 is severe agitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation. | Baseline and 15, 30, 60, 90, and 120 minutes | Severity of agitation will be measured using the standardized Agitation-Calmness Evaluation Scale. The 9-point scale indicated the degree of agitation as follows: 1=marked agitation, 4=normal behavior, 7 = marked calmness, 9=unarousable. |
| Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation. | Baseline and 15, 30, 60, and 90 minutes | Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score \>=14 and \<20; and \>= 20 is severe agitation. |
| Patient tolerability assessed by adverse events of dexmedetomidine | Baseline through 120 minutes after medication administration | Tolerability and safety of sublingual dexmedetomidine was assessed by evaluating spontaneously-reported adverse events. Treatment tolerability as assessed by adverse events will be tabulated by toxicity grade and organ systems as well as overall. |
| Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ) | Administered 120 minutes after medication administration | Medication Satisfaction Questionnaire (MSQ) will be given to the subject to assess their satisfaction of their agitation medication two hours after initial medication administration. The Medication Satisfaction Questionnaire is a 7-point scale, with 1 being Extremely Dissatisfied, 4 being Neither Satisfied or Dissatisfied, and 7 being Extremely Satisfied |
| Assess the need for rescue medication for agitation within two hours of medication administration | Baseline and 2 hours after medication administration | Need for rescue medication of sublingual dexmedetomidine will be assessed by reviewing the Medication Administration Reconciliation (MAR) available on the electronic medical record system for the two hour period of time following medication administration. |
Countries
United States
Contacts
Primary ContactJustin Faden, DO
Backup ContactMeghan Musselman, MD
Outcome results
None listed