Examination of Glutamate and mGluR5 in Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Evidence of glutamate availability (mGluR5) in psychiatric disorders confirmed by MRI and PET data.
研究概览
简要总结
This research study is designed to look at the involvement of the glutamate system in depression. Each subject will undergo a screening appointment to determine study eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule availability and will consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing. Depending on camera time, staff availability and subject schedule, total study participation may last 1-2 months.
详细描述
With the recent advancements in positron emission tomography (PET) and radioligand development, the investigators are now able to image and quantify the metabotropic glutamatergic system (mGluR5) in vivo in human subjects. The study proposes a novel investigation of mGluR5 in depression to obtain critical data to advance understanding of the etiology of depression and its associated symptoms of cognitive dysfunction.
Aim 1: To determine mGluR5 availability in individuals with mood disorders compared to healthy controls as measured with PET brain imaging.
Hypothesis 1: The study hypothesizes a decrease in mGluR5 availability in individuals with mood disorders in regions responsible for emotional and cognitive processes, including the amygdala, hippocampus, thalamus, anterior cingulate, and frontal cortices.
Aim 2: To determine if glutamate cycling in individuals with mood disorders is altered as compared to healthy controls as measured with [1H]MRS and [13C]MRS.
Hypothesis 2: The study hypothesizes an increase in glutamate number in individuals with mood disorders as compared to controls.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General inclusion criteria:
- •Subjects will be between the ages of 18-70 years old
- •English speaking
- •No other DSM-5 diagnosis present, besides required as below
- •Inclusion criteria for acute depressed subjects:
- •Clinical diagnosis of a current depressive episode
- •Medication-free for at least 2 weeks or medicated with a permissible medication
- •Inclusion criteria for PTSD subjects:
- •Clinical diagnosis of current PTSD as per DSM-5
- •Medication free for at least 2 weeks or medicated with a permissible medication
- •Inclusion criteria for healthy controls:
- •No current, or history of, any DSM-5 diagnosis
排除标准
- •Have a current or past significant medical, neurological or metabolic disorder or head injury that lead to significant long term decline in cognitive abilities as seen by decline in grades or work performance
- •Have significant medical illness such that would contraindicate study participation based on above criteria and PI/MD history review
- •Have active, significant suicidal ideation
- •Have implanted metallic devices or any MR contraindications
- •Are women who are pregnant or breastfeeding
- •Met DSM-5 criteria for mild substance use disorder (except nicotine and marijuana) within the past 6 months or met DSM-5 criteria for moderate to severe substance use disorder (except nicotine and marijuana) within the past year
- •Have history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
- •Have given a blood donation within eight weeks of the start of the study
- •Have history of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
研究组 & 干预措施
Cognitive Testing
Cognitive assessments
干预措施: Cognitive Testing (Behavioral)
Positron Emission Tomography
All subjects will have PET scan using FPEB or ABP688.
干预措施: PET (Radiation)
Magnetic Resonance Imaging
All subjects will have one MRI with a possibility of one functional MRI (fmri).
干预措施: MRI (Other)
结局指标
主要结局
Evidence of glutamate availability (mGluR5) in psychiatric disorders confirmed by MRI and PET data.
时间窗: Through study completion date, an average of 4 years.
次要结局
未报告次要终点