Back to resultsEvaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Primary Purpose
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Lorazepam 2 MG/ML
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Agitation focused on measuring Agitation, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Eligibility 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: Methadone Midazolam Opioids 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)
Sites / Locations
- Temple University Episcopal HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexmedetomidine
Lorazapem
Arm Description
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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"
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.
Full Information
NCT ID
NCT06093451
First Posted
October 5, 2023
Last Updated
October 16, 2023
Sponsor
Temple University
Collaborators
BioXcel Therapeutics Inc
1. Study Identification
Unique Protocol Identification Number
NCT06093451
Brief Title
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Official Title
An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
Collaborators
BioXcel Therapeutics Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
Keywords
Agitation, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.
Arm Title
Lorazapem
Arm Type
Active Comparator
Arm Description
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Igalmi
Intervention Description
Moderate agitation: 120 mcg Severe agitation: 180 mcg
Intervention Type
Drug
Intervention Name(s)
Lorazepam 2 MG/ML
Other Intervention Name(s)
Ativan
Intervention Description
2 mg
Primary Outcome Measure Information:
Title
Change in PANSS-EC score at 120 minutes after medication administration
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.
Description
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
Title
Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.
Description
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
Title
Patient tolerability assessed by adverse events of dexmedetomidine
Description
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
Title
Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)
Description
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
Title
Assess the need for rescue medication for agitation within two hours of medication administration
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Methadone
Midazolam
Opioids
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Faden, DO
Phone
2157070401
Email
Justin.Faden@tuhs.temple.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Musselman, MD
Phone
2157078483
Email
Meghan.Musselman@tuhs.temple.edu
Facility Information:
Facility Name
Temple University Episcopal Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19125
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
27857778
Citation
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Results Reference
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PubMed Identifier
26234333
Citation
Cots F, Chiarello P, Perez V, Gracia A, Becerra V. Hospital Costs Associated With Agitation in the Acute Care Setting. Psychiatr Serv. 2016 Jan;67(1):124-7. doi: 10.1176/appi.ps.201400508. Epub 2015 Aug 3.
Results Reference
background
PubMed Identifier
25881240
Citation
Rubio-Valera M, Luciano JV, Ortiz JM, Salvador-Carulla L, Gracia A, Serrano-Blanco A. Health service use and costs associated with aggressiveness or agitation and containment in adult psychiatric care: a systematic review of the evidence. BMC Psychiatry. 2015 Mar 4;15:35. doi: 10.1186/s12888-015-0417-x.
Results Reference
background
PubMed Identifier
22461917
Citation
Richmond JS, Berlin JS, Fishkind AB, Holloman GH Jr, Zeller SL, Wilson MP, Rifai MA, Ng AT. Verbal De-escalation of the Agitated Patient: Consensus Statement of the American Association for Emergency Psychiatry Project BETA De-escalation Workgroup. West J Emerg Med. 2012 Feb;13(1):17-25. doi: 10.5811/westjem.2011.9.6864.
Results Reference
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PubMed Identifier
22461918
Citation
Wilson MP, Pepper D, Currier GW, Holloman GH Jr, Feifel D. The psychopharmacology of agitation: consensus statement of the american association for emergency psychiatry project Beta psychopharmacology workgroup. West J Emerg Med. 2012 Feb;13(1):26-34. doi: 10.5811/westjem.2011.9.6866.
Results Reference
background
PubMed Identifier
26973742
Citation
Zeller SL, Citrome L. Managing Agitation Associated with Schizophrenia and Bipolar Disorder in the Emergency Setting. West J Emerg Med. 2016 Mar;17(2):165-72. doi: 10.5811/westjem.2015.12.28763. Epub 2016 Mar 2.
Results Reference
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PubMed Identifier
35191924
Citation
Preskorn SH, Zeller S, Citrome L, Finman J, Goldberg JF, Fava M, Kakar R, De Vivo M, Yocca FD, Risinger R. Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder: A Randomized Clinical Trial. JAMA. 2022 Feb 22;327(8):727-736. doi: 10.1001/jama.2022.0799.
Results Reference
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PubMed Identifier
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Citation
Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.
Results Reference
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Citation
Igalmi [package insert]. BioXcel Therapeutics, Inc; 2022.
Results Reference
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Learn more about this trial
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
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