A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting
研究概览
简要总结
This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Self-identifying Latinx, Spanish-speaking
- •Adults 18-64 years
- •Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician
- •Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline
- •Participants must have an MGB psychiatrist and primary care provider.
排除标准
- •History of primary psychotic disorder, by history
- •History Bipolar I disorder, by history
- •Unstable complex PTSD, as assessed by study clinician
- •History of dissociative identity disorder
- •History of neurocognitive disorder
- •History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
- •Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be <140/90 mmHg.
- •History of aortic dissection
- •History of myocardial infarction
- •History of aneurysm
- •History of hepatic impairment.
- •History of epilepsy
- •History of prior hypersensitivity to ketamine
- •Body Mass Index greater than 35
- •Body Mass Index less than 18.5
- •Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
- •Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
- •Inability to provide consent.
研究组 & 干预措施
Open label
Open label, single arm study
干预措施: Ketamine-assisted psychotherapy (Drug)
结局指标
主要结局
Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting
时间窗: 1 week post-intervention
(a) Assess the attendance and adherence rates of participants to the group-based ketamine intervention sessions; (b) Evaluate the feasibility of delivering the intervention sessions as planned, including the preparatory, dosing, and integration sessions; (c) Explore the perceptions and experiences of Spanish-speaking participants regarding the intervention.
To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.
时间窗: 1 week post-intervention
(a) assess safety as obtained through vital monitoring; heart-rate variability (HRV) monitoring, EKG, as measured by a Fitbit. (b) evaluate physical and psychological adverse effects at each study visit.
次要结局
- Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression.(1 and 12 weeks post-intervention)
研究者
Juliana Zambrano, MD, MPH
Psychiatrist
Massachusetts General Hospital