The Role of mGluR5 in CBT-I
Purpose
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.
Condition
- Major Depressive Disorder (MDD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with PET using [11C]ABP688) and sleep latency (with polysomnography study performed in a Sleep Lab Facility), CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi, pronounced "shut eye").
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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). |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Stony Brook University
Detailed Description
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).
