Use of Transmucosal Ketamine in Post Stroke Depression
试验速览
- 阶段
- 1 期
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms measured by the MADRS.
研究概览
简要总结
Studies have shown that ketamine is very effective and has a quick onset in treatment of depression. Most of these studies used intravenous ketamine in an inpatient setting and there are no large trials examining its use in Post Stroke Depression (PSD). There have been only few studies that have used other routes of administration (i.e., oral, transmucosal, intranasal, intramuscular) of ketamine which provided symptom relief for depression. The purpose of this study is to assess the effectiveness and safety of use of transmucosal ketamine in treatment of PSD. We hypothesize that fast acting antidepressant effects can be achieved with tolerable side effects for translation into the general post-stroke population. To test our hypothesis, the specific aim is to: (1) demonstrate that transmucosal administration of ketamine is feasible within the post-stroke depression population and has tolerable side effects. Exploratory aims will include assessment if ketamine also produces fast acting antidepressant effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (18 years of age or older) of any ethnicity diagnosed with Major Depressive Disorder (DSM-V criteria), who have had failed to respond to prior therapy (as defined as at least one anti-depressant trial or patient was intolerant or noncompliant with anti-depressive medications).
- •Willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing.
- •Understands and willing to undergo risks associated with adverse effects of study medications.
- •Willing to comply with restrictions and instructions disclosed in the consent form.
排除标准
- •Patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration
- •Patients with a diagnosis of epilepsy
- •Patients with a significant history of high intraocular pressure.
- •Patients with life threatening medical problems.
- •Participant is pregnant or breastfeeding.
- •Infants and children
- •Patients who lack medical decision-making capacity
- •Patients who would require medication adjustment during time in the study.
- •Known hypersensitivity to the study drug (ketamine).
- •Unwilling to undergo risks associated with adverse effects of study drugs.
- •Unwilling to comply with restrictions and instructions disclosed in the consent form
研究组 & 干预措施
Ketamine dose
The recommended ketamine dose of 0.5 mg/kg will be administered using a transmucosal route of administration wherein the subject will be instructed to place the liquid solution beneath their tongue and hold it in their mouth for 5 minutes. The pharmacy will prepare two 0.5 mg/kg solutions of ketamine in two syringes for each subject based on subject weight. For example, a 70 kg adult subject will receive a 0.35 mL solution of ketamine. The patient will receive a dose every 7 days for two weeks, for a total of two doses.
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in depressive symptoms measured by the MADRS.
时间窗: 14-day dosing period.
The Montgomery-Asberg Depression Rating Scale is a ten-item diagnostic questionnaire used by mental health clinicians to measure the severity of depressive episodes in subjects with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. "Reduction of MADRS" = 50% drop in total score as compared to baseline, a score of 0-8 indicating NO depression OR a decrease from a more severe category to a more mild one.
Change in depressive symptoms measured by the MADRS-S.
时间窗: 14-day dosing period.
Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S). The overall score ranges from 0-54 with a higher scores indicating more depression.
次要结局
- Side effects will be evaluated using the PRISE.(14-day dosing period.)
研究者
Amelia Adcock
Associate Professor
West Virginia University