NCT07095205RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 15 Jul 2025
- Start date
- 3 Oct 2024
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Stony Brook University
- Diseases
- Depression
- NCT number
- NCT07095205
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 14
- From 3 Oct 2024 to the primary completion date, 30 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
- 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.
Other illness
- 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.
- 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.
Other
- For Non-Depressed Participants:
- Blood donation within 8 weeks of the \[18F\]VAT scan.
- For Participants with MDD
- Significant risk for suicide.
- Blood donation within 8 weeks of the \[18F\]VAT scan.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stony Brook University: Dept of Psychiatry Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.