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临床试验/NCT05629520
NCT05629520已完成不适用

Inflammatory, Behavioral and Neural Markers of Anhedonia in Major Depressive Disorder

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Blood oxygen level dependent (BOLD) activation during reward-based tasks

研究概览

简要总结

The purpose of this research study is to better understand anhedonia in Major Depressive Disorder by investigating the reward-related neural and inflammatory correlates.

详细描述

Background: Despite extensive research on the treatment of Major Depressive Disorder (MDD) relapse rates are as high as 80%. Of those, 30-40% fall into the severe spectrum called treatment resistant depression (TRD) as they fail to respond to at least two lines of antidepressant treatment interventions. TRD has been linked with anhedonia, the inability to experience pleasure or interest in usually enjoyable activities. The neurobiology of anhedonia is poorly understood with recent literature examining an inflammatory association and linking it to deficits in reward-related brain circuitry. The present study examines neurobiological correlates of anhedonia in MDD and TRD, specifically C-Reactive Protein (CRP), IL-6 and ventral striatal (VS) activity. The study also explores whether VS activity mediates the association between inflammation and anhedonia.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Current diagnosis of MDD based on the MINI International Neuropsychiatric Interview (MINI)
  • For treatment resistant depression participants: unsuccessful treatment with at least 2 types or doses of antidepressant medication treatment
  • Right-handed
  • Capacity for informed consent
  • Score a 9 or higher on the MADRS

排除标准

  • Comorbid Bipolar Disorder
  • Substance use disorder in the last 12 months
  • Schizophrenia, and other psychotic disorders
  • Comorbid illness such as endocrinological illness (e.g. Cushing's disease) rheumatologic illness (e.g., systemic Lupus erythematosus, current treatment with glucocorticoids), and autoimmune diseases (e.g. psoriasis)
  • Pregnancy
  • Daily NSAID or aspirin use and any metallic implant
  • Visual/Hearing Impairments that would keep participant from being able to complete tasks

结局指标

主要结局

Blood oxygen level dependent (BOLD) activation during reward-based tasks

时间窗: 1 hour

Participants will undergo functional magnetic resonance imaging (fMRI) while completing the tasks in Outcome 2. Ventral striatum activation during the tasks will be measured by % BOLD signal change. The expected signal change is between .1-.8%.

Basal inflammatory marker assessment

时间窗: 1 hour

Quantify the profile of basal inflammatory markers (IL-6 and C-reactive protein) in blood. Blood will be collected within an hour after consent and will be processed by 3 hours.

Behavior during reward-based task - Reward Probabilistic Reversal Learning Task

时间窗: 30 minutes

Participants will complete a Reward Probabilistic Reversal Learning Task, a reward-based task, while undergoing functional magnetic resonance imaging (fMRI). Results will include choice behavior, either choice A or choice B, (button press) for this task.

Behavior during reward-based task - Monetary Incentive Delay Task

时间窗: 30 minutes

Participants will complete the Monetary Incentive Delay (MID) task, a reward-based task, while undergoing functional magnetic resonance imaging (fMRI). Results will include button press reaction time for the MID task.

次要结局

  • Mediation model between inflammation and anhedonia(3 hours)
  • Exploratory analysis of reward related regions(3 hours)
  • Exploratory inflammatory marker assessment(3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dahlia Mukherjee

Assistant Professor of Psychiatry and Behavioral Health

Milton S. Hershey Medical Center

研究点 (1)

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