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The Role of mGluR5 in CBT-I

The Role of mGluR5 in CBT-I

Recruiting
18 years and older
All
Phase 4

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Overview

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.

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

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 details
    Major Depressive Disorder (MDD)

NCT07076342

Stony Brook University

15 October 2025

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