RecruitingPhase 4NCT07076342

The Role of mGluR5 in CBT-I

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)


Sponsor

Stony Brook University

Enrollment

42 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a brain chemical receptor called mGluR5 plays a role in how cognitive behavioral therapy for insomnia (CBT-I) works in people with moderate-to-severe depression. **You may be eligible if...** - You are 18 years or older and in good physical health - You have been diagnosed with major depressive disorder (MDD) with a current depressive episode - Your depression is at least moderate in severity (MADRS score above 29) - Your sleep problems include difficulty falling asleep (sleep latency up to 128 minutes) - You are not currently taking effective antidepressant medication **You may NOT be eligible if...** - You have a history of psychosis - You have had drug or alcohol dependence in the past 6 months or abuse in the past 2 months - You have an unstable medical condition - You have used nicotine in the past year - You are currently taking medication known to affect glutamate levels in the brain - You have sleep disorders beyond insomnia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet Sleep Healthy Using The Internet (SHUTi)

DRUGPET Scan with [11C]ABP688

Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer \[11C\]ABP688) to quantify hippocampal mGluR5 density.


Locations(1)

Stony Brook University: Dept of Psychiatry

Stony Brook, New York, United States

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NCT07076342


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