Genetic Markers Associated With Response to Intravenous Ketamine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder 7-item
研究概览
简要总结
The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Must have received IV ketamine previously to treat Treatment-Resistant Depression
- •Between the ages of 18-65 years old.
- •Clinical diagnosis of MDD
- •Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
- •Ability to provide informed consent
排除标准
- •Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
- •Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- •Individuals who are unable to consent to the procedure.
- •Individuals who are unable to adhere to the protocol in its totality
结局指标
主要结局
Generalized Anxiety Disorder 7-item
时间窗: Over 1-2 weeks
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. The scale ranges from 0 (not at all) to 3 (nearly every day). To total score ranges from 0 suggesting a lack anxiety symptoms to 21, indicating severe anxiety.
Snaith-Hamilton Pleasure Scale
时间窗: Over 1-2 weeks
The SHAPS assessment is a 14 item self report tool used to measure anhedonia. Each item can be have a response of 1 (Definitely agree), 2(Agree), 3(Disagree), and 4(definitely disagree). The total score ranges from 14 to 56, in which higher scores on the assessment indicate higher levels of anhedonia.
Genetic Biomarkers
时间窗: 1 month
Genetic markers associated with metabolism of IV ketamine will be assessed
Quick Inventory of Depressive Symptomatology Self Report 16-Item
时间窗: Over 1-2 weeks
The QIDS-SR16 is a self-report assessment used to evaluate depression severity in patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of Major Depressive Episode. In total, there are 16 individual questions evaluating 9 DSM domains. The highest score is 27, indicating severe depression, while the lowest score is 0, which would suggest a complete absence of depressive symptoms.
Clinician Administered Dissociative States Scale
时间窗: Over 1-2 weeks
The CADSS is a 23-item assessment administered by a clinician in order to evaluate dissociative symptoms. Each item is evaluated on a scale from 0, suggesting no dissociative symptom, to 4, suggesting extreme dissociation. In total, patients can score between 0 to 92, indicating extreme dissociation.
Sheehan Disability Scale
时间窗: Over 4 initial infusions
The SDS contains 3 items, each ranging between zero to ten. The SDS is a self-reported assessment of disability within the context of depression. The total score ranges from 0, indicating no impairment, to 30, indicating severe impairment.
次要结局
- UCLA Loneliness Scale (UCLA)(1 month)
- Diet Screener Questionnaire(1 month)
- Work Productivity and Activity Impairment Questionnaire (WPAI)(1 month)
- Childhood Trauma Questionnaire (CTQ)(1 month)
- Perceived Health Questionnaire (PHQ)(1 month)
- Mystical Experience Questionnaire (MEQ)(1 month)
- Quality of Life Questionnaire (EQ-3D-5L)(1 month)