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The Role of mGluR5 in CBT-I

RECRUITINGPhase 4Sponsored by Stony Brook University
Actively Recruiting
PhasePhase 4
SponsorStony Brook University
Started2025-08-01
Est. completion2030-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

DepressionMajor Depressive Disorder (MDD)

Locations1 site

Stony Brook University: Dept of Psychiatry
Stony Brook, New York, 11794
Christine DeLorenzo, PhD(631) 638-1523Christine.DeLorenzo@stonybrookmedicine.edu

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