Acute Agitation in Emergency Psychiatry

Официальное название

Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry

Обзор

The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

Подробное описание

The initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. With this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. After obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. The proposed platform design aims to anwer the question What is the best treatment for acutely agitated patients in inpatient psychiatric settings?

Вмешательства

• Препарат Sublingual Dexmedetomidine
  Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs
• Препарат Buccal midazolam
  Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs
• Препарат Oral lorazepam
  Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs

Первичные конечные точки

• The Excited Component of the Positive and Negative Syndrome Scale (PEC) [Срок оценки: 60 minutes]

Вторичные конечные точки (6)

• PEC score earliest time with difference [Срок оценки: 30, 60, 90, and 120 minutes]
• Tranquillized or asleep [Срок оценки: 30, 60, 90, and 120 minutes post-dose]
• Physical restraint [Срок оценки: 12 hours post-dose]
• Mechanical restraint [Срок оценки: 12 hours post-dose]
• Rescue medication [Срок оценки: 4-12 hours post-dose]
• Patient-reported satisfaction [Срок оценки: From 2 to 24 hrs post-dose when the participant is able to cooperate]

Критерии участия

Критерии включения

• 18-64 years
• Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms
• Total score of ≥14 on the PANSS Excited Component (PEC)
• A score ≥4 on at least 1 of the 5 items of the PEC
• Informed consent obtained prior to the occurrence of the emergency

Критерии исключения

• Involuntary psychiatric admission according to the Danish Mental Health Act
• Female patients who are breastfeeding
• Female patients aged <50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives
• Body weight <50 kg
• Extreme obesity defined as estimated BMI≥ 40 kg/m2
• Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)
• The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)
• Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)
• Clinical suspicion of contraindications for one of the treatment arms
• Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment
• Known allergy to any of the study medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Mental Health Center Copenhagen, Bispebjerg — Copenhagen N

Идентификаторы

NCT: NCT06752616 · 2023-510201-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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