Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Sleep Latency from Baseline to 8 Weeks
研究概览
简要总结
This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.
详细描述
Cognitive behavioral therapy for insomnia (CBT-I), a treatment solely aimed at improving sleep, reduces depression with rates similar to conventional antidepressants. Although this efficacy reflects the interrelationship between sleep and depression, CBT-I's antidepressant mechanism of action is currently unknown. One potential mechanistic pathway is through the metabotropic glutamate receptor subtype 5 (mGluR5), due to its strong association with both depression and sleep. The investigators hypothesize that CBT-I's antidepressant efficacy may occur through the downregulation of mGluR5 associated with improved sleep. This study is a mechanistic clinical trial in a cohort of adults with MDD and a range of sleep latencies (time it takes to fall asleep). Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with using positron emission tomography [PET] imaging) and sleep latency (with polysomnography performed in the Sleep Lab). CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •capacity to provide informed consent,
- •at least 18 years of age
- •good physical health and absence of significant medical conditions,
- •diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria
- •Montgomery-Åsberg Depression Rating Scale (MADRS) score > 29 (at least moderate depression),
- •uniform range of sleep latencies up to 128 minutes.
排除标准
- •currently taking effective antidepressants,
- •lifetime history of psychosis,
- •drug or alcohol dependence in the last 6 months or abuse in the last 2 months
- •unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)
- •nicotine use within 1 year
- •currently on medication known to affect glutamate,
- •sleep disorders, other than insomnia, such as sleep apnea,
- •recent (within 1 year) regular night shift work (or rotating shift work) or recent (within 3 months) travel across more than one time zone, or plans for this work or travel during the study period,
- •use of medication or substances that affect sleep, for example, ingestion of more > 600 mg of caffeine per day,
- •PET or MRI contraindications, including pregnancy or currently breastfeeding
研究组 & 干预措施
Cognitive Behavioral Therapy for Insomnia Treatment Arm
Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy for Insomnia Treatment Arm
Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
干预措施: PET Scan with [11C]ABP688 (Drug)
结局指标
主要结局
Change in Sleep Latency from Baseline to 8 Weeks
时间窗: Baseline and 8 Weeks
Polysomnography: Prior to and following CBT-I, participants will spend one or two nights in the facility's Sleep Lab in order to assess sleep latency (i.e., quantity of sleep). While the participant sleeps, polysomnography, including EEG will be collected. This will be used to quantify sleep latency.
Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment
时间窗: Baseline and 8 weeks
PET Imaging: Prior to and following CBT-I, participants will receive PET imaging to allow measurement of change in mGluR5 (a protein receptor in the brain) density in the hippocampus.
次要结局
未报告次要终点
研究者
Christine DeLorenzo
Professor of Psychiatry & Biomedical Engineering, Director (CUBIT)
Stony Brook University