Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [18F]VAT to Assess the Antidepressant Effect of Nicotine
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale-17 (HAMD) score.
研究概览
简要总结
In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •For Non-Depressed Participants:
- •Age range 18 to 65 years old.
- •Capacity to consent (able to read, understand, and sign informed consent).
- •For Participants with MDD
- •Age range 18 to 65 years old.
- •Capacity to consent (able to read, understand, and sign informed consent).
- •Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode
- •Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).
排除标准
- •For Non-Depressed Participants:
- •Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year [except for occasional users, who cannot use nicotine products in the week before the scan].
- •Need for use of medication during the study that will affect cholinergic levels.
- •Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
- •Significant active physical illness or neurological deficit that may affect brain function or imaging.
- •Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
- •Current or lifetime history of a major psychiatric diagnosis.
- •Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
- •Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
- •Blood donation within 8 weeks of the [18F]VAT scan.
- •For Participants with MDD
- •Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year [except for occasional users, who cannot use nicotine products in the week before the scan].
- •Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.
- •Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
- •Significant active physical illness or neurological deficit that may affect the brain function or imaging.
- •Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
- •Current or lifetime major psychiatric diagnosis other than MDD.
- •Life-time history of psychosis or current psychosis.
- •Significant risk for suicide.
- •Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
- •Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
- •Blood donation within 8 weeks of the [18F]VAT scan.
研究组 & 干预措施
Control
This arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer [18F] VAT to measure cholinergic terminal density.
干预措施: PET Scan with [18F] VAT (Drug)
Major Depressive Disorder (MDD)
This arm consists of participants diagnosed with Major Depressive Disorder. Participants in the MDD arm will receive interventional treatment for 8 days with transdermal nicotine patches. Participants in the MDD arm will also receive two PET scans with [18F]VAT tracer: one at baseline and one post-treatment.
干预措施: PET Scan with [18F] VAT (Drug)
Major Depressive Disorder (MDD)
This arm consists of participants diagnosed with Major Depressive Disorder. Participants in the MDD arm will receive interventional treatment for 8 days with transdermal nicotine patches. Participants in the MDD arm will also receive two PET scans with [18F]VAT tracer: one at baseline and one post-treatment.
干预措施: Nicotine transdermal patch (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale-17 (HAMD) score.
时间窗: Before and after 8 days of treatment with nicotine.
Description: Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment. Minimum score 0, maximum possible score 52, with remission defined as \<=7. The higher the score on the scale, the more severe the degree of depression.
次要结局
未报告次要终点
研究者
Ramin Parsey
Professor of Psychiatry, Director of PET Strategy (M.D., Ph.D.)
Stony Brook University