The Role of mGluR5 in CBT-I
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)
Stony Brook University
42 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet Sleep Healthy Using The Internet (SHUTi)
Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer \[11C\]ABP688) to quantify hippocampal mGluR5 density.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07076342