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NCT Number: NCT07095205

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stony Brook University: Dept of Psychiatry

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Julianna Lizzul

CONTACT

[email protected]

631-638-0291

Ramin Parsey, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.
  • Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
  • Current or lifetime major psychiatric diagnosis other than MDD.
  • Life-time history of psychosis or current psychosis.
  • Significant risk for suicide.
  • 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.

Treatment and study plan

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).

Other names: Nicorette NicoDerm CQ, Nicotine patch

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.

Primary outcomes

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

    Time frame: Before and after 8 days of treatment with nicotine.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julianna Lizzul

CONTACT

[email protected]

631-638-0291

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: VATMDDNicotine

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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