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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
View on ClinicalTrials.gov →
NCT07076342
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
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Actively Recruiting
PhasePhase 4
SponsorStony Brook University
Started2025-08-01
Est. completion2030-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07076342