NCT07095205 PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.
| NCT ID | NCT07095205 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Stony Brook University |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 14 participants in total. It began in 2024-10-03 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ramin Parsey, MD, PhD
PRINCIPAL INVESTIGATOR
Stony Brook University
Frequently Asked Questions
Who can join the NCT07095205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07095205 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07095205 currently recruiting?
Yes, NCT07095205 is actively recruiting participants. Contact the research team at julianna.lizzul@stonybrookmedicine.edu for enrollment information.
Where is the NCT07095205 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT07095205 clinical trial?
NCT07095205 is sponsored by Stony Brook University. The principal investigator is Ramin Parsey, MD, PhD at Stony Brook University. The trial plans to enroll 14 participants.