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Recruiting NCT07095205

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

Phase IV Interventional Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotine transdermal patch, PET Scan with [18F] VAT.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Nicotine 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).
  • Drug PET 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.

Primary outcome measures

  • Change in Hamilton Depression Rating Scale-17 (HAMD) score. [Time frame: Before and after 8 days of treatment with nicotine.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stony Brook University: Dept of Psychiatry — Stony Brook

Identifiers

NCT: NCT07095205 · IRB2023-00490 · 1R21MH137546-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗