Unraveling the Aesthetic Mind in Anhedonia, Insights From Pharmacological Imaging of the Human Brain: A Single-blind, Randomized, Placebo-controlled Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- BOLD signal assessed with fMRI during sexual arousal paradigm
研究概览
简要总结
The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General health based on medical history and physical examination
- •Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
- •Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
- •Age 18 to 55 years
- •Right-handedness (due to potential lateralization effects of lefthanded subjects)
- •Willingness and competence to sign the informed consent form
排除标准
- •Current or history of neurological disease
- •Current medical illness requiring treatment
- •Psychiatric diagnosis for healthy individuals
- •Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
- •Pregnancy or current breastfeeding
- •Current or former substance abuse
- •Previous ketamine use in lifetime
- •Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
- •Failure to comply with the study protocol or to follow the instruction of the investigating team
研究组 & 干预措施
Ketamine first, then placebo
0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo
干预措施: Placebo (Drug)
Ketamine first, then placebo
0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo
干预措施: Ketamine (Drug)
Placebo frist, then ketamine
0.9% NaCl, then ketamine
干预措施: Ketamine (Drug)
Placebo frist, then ketamine
0.9% NaCl, then ketamine
干预措施: Placebo (Drug)
结局指标
主要结局
BOLD signal assessed with fMRI during sexual arousal paradigm
时间窗: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a sexual arousal paradigm
BOLD signal assessed with fMRI during aesthetic paradigm
时间窗: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during an aesthetic processing task
BOLD signal assessed with fMRI during resting state
时间窗: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state
BOLD signal assessed with fMRI during reward paradigm
时间窗: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a reward processing task
Levels of pleasantness assessed during aesthetic fMRI task
时间窗: Change from baseline to up to 4 weeks
Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task
Number of of chills assessed during aesthetic fMRI task
时间窗: Change from baseline to up to 4 weeks
Number of chills in response to aesthetic stimuli during aesthetic paradigm task
次要结局
未报告次要终点
研究者
Rupert Lanzenberger
Principle Investigator
Medical University of Vienna