NCT07076342PHASE4Recruiting

The Role of mGluR5 in CBT-I

Stony Brook University

Start Date

8/1/2025

Completion Date

3/31/2030

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.

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

DRUG

PET Scan with [11C]ABP688

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Conditions

Major Depressive Disorder (MDD)

Locations

Stony Brook University: Dept of Psychiatry

Stony Brook, New York 11794

United States