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临床试验/NCT03026036
NCT03026036已完成不适用

Neuroimaging Studies of Reward Processing in Depression

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
MRI Data

研究概览

简要总结

This study investigates stress-related signaling of glutamate and dopamine within the reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to predict depressive symptoms in the future. This will be achieved through various neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.

详细描述

The overarching goals of this research are to investigate: (1) stress-induced glutamatergic abnormalities and their relation to disruption within the corticostriatal valuation circuit in MDD; (2) stress-induced DA signaling disruptions in MDD; and (3) the predictive validity of these two pathophysiological mechanisms. This will be achieved through an innovative integration of (1) proton magnetic resonance spectroscopy (MRS)-based assessments of glutamatergic metabolites in the mPFC; (2) functional magnetic resonance imaging (fMRI) probes of the corticostriatal valuation circuit with well-established stress manipulations (MAST) and assessments (cortisol and inflammatory markers); (3) positron emission tomography (PET)-based measurement of striatal DA release with well-established stress manipulations and assessments (cortisol and inflammatory markers); and (4) a naturalistic follow-up design.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All genders, races, and ethnic origins, aged between 18 and 45
  • Capable of providing written informed consent, and fluent in English
  • Right-handed
  • Absence of any psychotropic medications for at least 2 weeks
  • Inclusion Criteria for Current Depression Group (MDD):
  • Current DSM-5 diagnostic criteria for MDD (as diagnosed with the use of the SCID)
  • Inclusion Criteria for Remitted Depression Group (rMDD):
  • History of at least one major depressive episode within the past five years
  • Not currently depressed
  • Inclusion Criteria for Healthy Control Group (HC):
  • Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse)

排除标准

  • Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
  • Pregnant women
  • Failure to meet standard MRI or PET safety requirements
  • Serious or unstable medical illness
  • History of seizure disorder
  • History or current diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, OCD, PTSD, mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion)
  • Simple phobia, social anxiety disorder, and generalized anxiety disorder will be allowed only if secondary to MDD and only in the MDD group
  • History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
  • History of use of dopaminergic drugs (including methylphenidate)
  • Patients with a lifetime history of electroconvulsive therapy (ECT)

结局指标

主要结局

MRI Data

时间窗: MRI scans for a total of 90 minutes take place within 30 days of Screening Visit

Behavioral Performance on the Probabilistic Stimulus Selection Task

时间窗: Screening visit (Day 0)

The Probablilistic Reward Task operationalizes positive reinforcement learning

Salivary Cortisol

时间窗: 6 times during MRI visit (on or before Day 30), and 4 times during PET visit (on or before Day 30)

Follow-up Clinical Interviews

时间窗: 6 months and 12 months after the MRI scanning visit

PET scan with raclopride

时间窗: a total of 90 minutes take place after the MRI data collection

Four Blood Samples (6ml)

时间窗: During the MRI visit (on or before Day 30)

Behavioral Performance on the Instrumental Learning Task

时间窗: Administered during MRI scan (on or before Day 30)

The instrumental learning task is designed to measure participant learning from reward and punishment.

次要结局

未报告次要终点

研究者

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

Diego Pizzagalli

Professor, Department of Psychiatry, Harvard Medical School

Mclean Hospital

研究点 (1)

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