Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

NCT06093451 | Unknown Phase 4 FDA Drug

• 1 other identifier: 30561
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Agitation; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at 120 minutes

Secondary Outcomes (5)

• 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

• 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

• Patient tolerability assessed by adverse events of dexmedetomidine

  Baseline through 120 minutes after medication administration

• Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)

  Administered 120 minutes after medication administration

• Assess the need for rescue medication for agitation within two hours of medication administration

  Baseline and 2 hours after medication administration

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Lorazapem

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

Moderate agitation: 120 mcg Severe agitation: 180 mcg

Also known as: Igalmi

Dexmedetomidine

Lorazepam 2 MG/ML DRUG

2 mg

Also known as: Ativan

Lorazapem

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Temple University: lead
• BioXcel Therapeutics Inc: collaborator

Study Sites (1)

Temple University Episcopal Hospital

Philadelphia, Pennsylvania, 19125, United States

RECRUITING

Related Publications (9)

• San L, Marksteiner J, Zwanzger P, Figuero MA, Romero FT, Kyropoulos G, Peixoto AB, Chirita R, Boldeanu A. State of Acute Agitation at Psychiatric Emergencies in Europe: The STAGE Study. Clin Pract Epidemiol Ment Health. 2016 Oct 27;12:75-86. doi: 10.2174/1745017901612010075. eCollection 2016.

  PMID: 27857778 BACKGROUND

• 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.

  PMID: 26234333 BACKGROUND

• 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.

  PMID: 25881240 BACKGROUND

• 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.

  PMID: 22461917 BACKGROUND

• 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.

  PMID: 22461918 BACKGROUND

• 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.

  PMID: 26973742 BACKGROUND

• 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.

  PMID: 35191924 BACKGROUND

• 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.

  PMID: 36198061 BACKGROUND

• Igalmi [package insert]. BioXcel Therapeutics, Inc; 2022.

  BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Psychomotor Agitation; Schizophrenia

Interventions

Dexmedetomidine; Lorazepam

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Justin Faden, DO

CONTACT

2157070401; Justin.Faden@tuhs.temple.edu

Meghan Musselman, MD

CONTACT

2157078483; Meghan.Musselman@tuhs.temple.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 23, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)