RecruitingRecruiting
The Role of mGluR5 in CBT-I
NCT07076342 · Stony Brook University
In plain English
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Official title
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)
About this study
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).
Eligibility criteria
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
Enrollment target: 42 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-01
Estimated completion: 2030-03-31
Last updated: 2026-02-17
Interventions
Behavioral: Cognitive Behavioral Therapy for InsomniaDrug: PET Scan with [11C]ABP688
Primary outcomes
- • Change in Sleep Latency from Baseline to 8 Weeks (Baseline and 8 Weeks)
- • Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment (Baseline and 8 weeks)
Sponsor
Stony Brook University · other
With: National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Contacts & investigators
ContactWendy Zhang · contact · Wendy.Zhang@stonybrookmedicine.edu · (631)-638-2053
ContactChristine DeLorenzo, PhD · contact · christine.delorenzo@stonybrookmedicine.edu · (631) 638-1523
All locations (1)
Stony Brook University: Dept of PsychiatryRecruiting
Stony Brook, New York, United States