A Phase 4 interventional study of Dexmedetomidine and Lorazepam 2 MG/ML in Schizophrenia Agitation, Schizo Affective Disorder and Bipolar Disorder, sponsored by Temple University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Temple University · Phase 4, Interventional, and Treatment
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.
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's planned enrollment of 32 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
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Exclusion Criteria:
Participant is receiving high-risk medications, including:
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.
Drug: Dexmedetomidine
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.
Drug: Lorazepam 2 MG/ML
Moderate agitation: 120 mcg Severe agitation: 180 mcg
Also known as: Igalmi
2 mg
Also known as: Ativan
Change in PANSS-EC score at 120 minutes after medication administration
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.
Time frame: Baseline and at 120 minutes
Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.
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.
Time frame: Baseline and 15, 30, 60, 90, and 120 minutes
Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.
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.
Time frame: Baseline and 15, 30, 60, and 90 minutes
Patient tolerability assessed by adverse events of dexmedetomidine
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.
Time frame: Baseline through 120 minutes after medication administration
Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)
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"
Time frame: Administered 120 minutes after medication administration
Assess the need for rescue medication for agitation within two hours of 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.
Time frame: Baseline and 2 hours after medication administration
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