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

NCT07095205 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: IRB2023-004901R21MH137546-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale-17 (HAMD) score.

  Description: Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment. Minimum score 0, maximum possible score 52, with remission defined as \<=7. The higher the score on the scale, the more severe the degree of depression.

  Before and after 8 days of treatment with nicotine.

Study Arms (2)

Control

EXPERIMENTAL

This arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer \[18F\] VAT to measure cholinergic terminal density.

Drug: PET Scan with [18F] VAT

Major Depressive Disorder (MDD)

EXPERIMENTAL

This arm consists of participants diagnosed with Major Depressive Disorder. Participants in the MDD arm will receive interventional treatment for 8 days with transdermal nicotine patches. Participants in the MDD arm will also receive two PET scans with \[18F\]VAT tracer: one at baseline and one post-treatment.

Drug: Nicotine transdermal patch; Drug: PET Scan with [18F] VAT

Interventions

Nicotine transdermal patch DRUG

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).

Also known as: Nicorette NicoDerm CQ, Nicotine patch

Major Depressive Disorder (MDD)

PET Scan with [18F] VAT DRUG

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.

Control; Major Depressive Disorder (MDD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Non-Depressed Participants:
• Age range 18 to 65 years old.
• Capacity to consent (able to read, understand, and sign informed consent).
• For Participants with MDD
• Age range 18 to 65 years old.
• Capacity to consent (able to read, understand, and sign informed consent).
• Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode
• Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).

You may not qualify if:

• For Non-Depressed Participants:
• Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
• Need for use of medication during the study that will affect cholinergic levels.
• Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
• Significant active physical illness or neurological deficit that may affect brain function or imaging.
• Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
• Current or lifetime history of a major psychiatric diagnosis.
• Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
• Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
• Blood donation within 8 weeks of the \[18F\]VAT scan.
• For Participants with MDD
• Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
• Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.
• Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
• Significant active physical illness or neurological deficit that may affect the brain function or imaging.

Sponsors & Collaborators

• Stony Brook University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stony Brook University: Dept of Psychiatry

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Tobacco Use Cessation Devices; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ramin Parsey, MD, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianna Lizzul

CONTACT

631-638-0291; julianna.lizzul@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Director of PET Strategy (M.D., Ph.D.)

Model Details: Participants diagnosed with Major Depressive Disorder (MDD) will receive two PET scans, one before and one after treatment. During the treatment period, 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). Non-depressed participants will have one PET scan and will not receive any nicotine treatment.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: October 3, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)