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The Role of mGluR5 in CBT-I

RecruitingPhase 4

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)

Who can join

Ages 18 and older · All sexes

Full 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-Ã…sberg 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

About the study

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.

What is being tested

Sponsor: Stony Brook University · Participants: 42 · Started: Aug 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07076342

Locations in the U.S.

New YorkStony Brook University: Dept of Psychiatry, Stony Brook

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.