NCT05168735已完成1 期
Ketamine + Mindfulness for Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- State Mindfulness Scale
研究概览
简要总结
In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.
详细描述
NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants will:
- •be between the ages of 18 and 65 years,
- •score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D)
- •possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
排除标准
- •All participants:
- •Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
- •Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- •Changes made to treatment regimen within 4 weeks of baseline assessment.
- •Reading level <6th grade as per patient self-report.
- •Patients who have received ECT in the past 2 months prior to Screening.
- •Current pregnancy or breastfeeding
- •Patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
- •Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for unreported drugs of abuse], vitals, or ECG.
- •Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
- •Patients with one or more seizures without a clear and resolved etiology.
- •Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
- •Past intolerance or hypersensitivity to ketamine.
- •Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [riluzole, amantadine, memantine, topiramate, dextromethorphan, D-cycloserine], or the mu-opioid receptor [opiate medications--morphine, oxycodone, heroin, fentanyl)]. However, lamotrigine will not be a study exclusion given that it has been shown not to impact ketamine's safety profile or its antidepressant efficacy.
- •Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
- •Patients who report meditating with mindfulness techniques >1 hour weekly (on average) for the past 6 months or longer.
研究组 & 干预措施
Intravenous Ketamine + Mindfulness Exercises
Experimental
干预措施: Brief Mindfulness Exercises (Behavioral)
Intravenous Ketamine + Academic Exercises
Active Comparator
干预措施: Academic Exercises (Behavioral)
Intravenous Ketamine + Academic Exercises
Active Comparator
干预措施: Intravenous Ketamine (Drug)
Intravenous Ketamine + Mindfulness Exercises
Experimental
干预措施: Intravenous Ketamine (Drug)
结局指标
主要结局
State Mindfulness Scale
时间窗: 80min post-infusion
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
Montgomery-Asberg Depression Rating Scale
时间窗: 30 days post-intervention
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
次要结局
- Hood Mysticism Scale(40 minutes post-intervention)
- Modified Hamilton Depression Rating Scale(30 days post-intervention)
- Daily Spiritual Experience Scale(30 days post-intervention)
- Quick Inventory of Depressive Symptoms(30 days post-intervention)
- Mindful Attention Awareness Scale(30 days post-intervention)
研究者
Rebecca Price
Associate Professor of Psychiatry and Psychology
University of Pittsburgh
研究点 (1)
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