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Идёт набор NCT06085937

Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

Фаза I С лечением Suicide Suicidal Ideation Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ketamine.
Кому может быть актуально
Состояния в реестре: Suicide, Suicidal Ideation, Depression. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department

Обзор

There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.

Подробное описание

In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.

Specific aims are as follows:

1. To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients. 2. To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient. 3. To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS. 4. To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.

Вмешательства

  • Препарат Ketamine
    Patients will receive 0.2mg/kg of IV ketamine

Первичные конечные точки

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: 2 hours]
  • Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility] [Срок оценки: 2 hours]
Вторичные конечные точки (2)
  • Change in Suicidal Ideation [Срок оценки: 72 hours]
  • Hospital Length of Stay [Срок оценки: up to 2 weeks]

Критерии участия

Критерии включения

  • Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
  • Require inpatient stabilization for SI or actions based on clinical observation and interview
  • Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
  • Have a Glasgow Coma Score (GCS) of 15
  • Age 18-65

Критерии исключения

  • Current or past history of psychosis
  • Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater
  • History of ketamine use disorder
  • History of liver transplant
  • Pregnancy or breastfeeding
  • Imprisonment or inability to consent
  • Positive urine drug screen or serum alcohol level
  • Hypertension (SBP > 160 or DBP > 100 before administration of ketamine)
  • Hypotension (SBP < 90)
  • Presence of acute medical condition requiring admission to medical service
  • Allergy, intolerance, or previous adverse reaction to ketamine
  • Patient has 8+ lifetime ketamine exposures
  • The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Kansas Strawberry Hill Campus — Kansas City
  • University of Kansas Medical Center Emergency Department — Kansas City

Идентификаторы

NCT: NCT06085937 · STUDY00150830

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗