Low Dose Ketamine Infusion for the Treatment of Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Participants Depressive Symptoms
研究概览
简要总结
The purpose of this investigator-initiated observational study is to examine how low Ketamine infusion treatments impact antidepressant and anti-suicidal effects for refractory and non-refractory depression.
详细描述
This is a descriptive research study that will be collecting prospective outcome data in patients who have been examined Psychiatry and the Intensive Care Unit attending. This study will follow the patients examined and screened by both Psychiatry and the Intensive Care Unit attending physician with orders for the use of ketamine bolus. This study will be examining outcomes of the treatment and will be conducted within adult patients The electronic health records will be reviewed for follow up.
The Primary Objective is to examine the use of Ketamine and the patient outcomes following treatment in individuals with treatment resistant depression. The subjects with treatment resistant depression will be identified by Psychiatric Consult using the Quick Inventory of Depressive Symptomatology evaluation tool, have treatment resistant depression, no history of psychosis, no active substance use, admitted to medical floor and confirmed acceptance to a local Behavioral Medical Center.
Procedures involved (Research Interventions):
Psychiatric consult that includes:
- A full diagnostic psychiatric interview will be conducted to determine referral appropriateness and discuss other options
- Review of systems and medical history completed
- Discussion of treatment alternatives
- Discussion of off-label use of Ketamine for treatment resistant depression
- Any necessary labs or additional consults will be suggested at this time. .
- Review the need to remain NPO for 8 hours prior to treatment and not to take benzodiazepines (i.e., Ativan, Valium, Xanax, Klonopin), alcohol or narcotics (i.e., oxycodone, oxycontin, dilaudid, etc.) within 8 hours of the treatment with the patient.
- Vitals Assessed on Evaluation - Cardiovascular parameters
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •treatment resistant depression
排除标准
- •Patients excluded by SICU/ER attending for treatment based on the following relative contraindications:
- •Coronary artery disease
- •Increased intraocular pressure (glaucoma)
- •Increased intracranial pressure
- •Uncontrolled hypertension
- •Kidney dysfunction
- •Liver dysfunction
- •Cardiac decompensation
- •Psychotic disorders (needs further evaluation)
结局指标
主要结局
Change in Participants Depressive Symptoms
时间窗: within 24 hours
The number of participants treated with Ketamine will have a change in their depressive symptoms using The Quick Inventory of Depressive Symptomatology (QIDS SR-16) completed pre and 24 hours post infusion by Psychiatry MD, vital signs pre, every 15 minutes during infusion and within 5 minutes of completion of infusion and every 15 minutes after until patient is has a PARS of 8 or greater or is back to baseline.
次要结局
未报告次要终点
研究者
Patti Radovich
Director of Nursing Research
Loma Linda University