RecruitingPhase 4NCT07095205

PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [18F]VAT to Assess the Antidepressant Effect of Nicotine

Sponsor

Stony Brook University

Enrollment

14 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of brain scan (PET imaging with a tracer called [18F]VAT) to explore whether nicotine has an antidepressant effect in the brain. Researchers want to see how nicotine affects a brain system (the cholinergic system) in both healthy people and people with major depressive disorder (MDD). **You may be eligible if...** - You are between 18 and 65 years old - You are able to understand and sign an informed consent form - AND if you have MDD: you are currently in a major depressive episode with a high depression score (MADRS of 29 or above) and depression is your primary diagnosis **You may NOT be eligible if...** - You have used nicotine products (cigarettes, vaping, patches, gum) in the past year (occasional users may qualify if they abstain for one week before the scan) - You are currently taking antidepressant medications (for MDD participants) or medications that affect the cholinergic brain system - You have a significant physical illness or neurological condition that affects the brain - You have certain serious eye conditions (e.g., keratoconus) - You have any MRI contraindications (metal implants, pacemaker, etc.) - You are pregnant, breastfeeding, or planning to conceive during the study - You have donated blood within the past 8 weeks 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

DRUGNicotine transdermal patch

The participants with MDD will receive Nicorette NicoDerm CQ nicotine transdermal patches for 8 days (7 mg/day for days 1-2, 14 mg/day for days 3-4, and 21 mg/day for days 5-8).

DRUGPET Scan with [18F] VAT

All participants will undergo a PET scan at Baseline using tracer \[18F\] VAT. Participants with MDD will undergo a second post-treatment PET scan using tracer \[18F\] VAT.