Major Depressive Disorder (MDD)Phase 4VATMDDNicotineNCT07095205
PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.
A Phase 4 study testing Nicotine transdermal patch and PET Scan with [18F] VAT in people with Major Depressive Disorder (MDD), run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Nicotine transdermal patch and PET Scan with [18F] VAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 30 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University: Dept of Psychiatry
Stony Brook, New York, 11794
Julianna Lizzul, 631-638-0291, julianna.lizzul@stonybrookmedicine.edu
Ramin Parsey, M.D., Ph.D.
About this study
Official title: Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Nicotine transdermal patch, PET Scan with [18F] VAT
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine transdermal patchDrug
Also called Nicorette NicoDerm CQ, Nicotine 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).
PET Scan with [18F] VATDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nicotine transdermal patch; Drug: PET Scan with [18F] VAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 8 days of treatment with nicotine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start3 Oct 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ramin Parsey, Stony Brook University
- Investigators
- Ramin Parsey, MD, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095205
- Sponsor's protocol ID
- IRB2023-00490
- Other IDs
- 1R21MH137546-01
- Acronym
- VATMDDNicotine
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [18F]VAT to Assess the Antidepressant Effect of Nicotine
- ClinicalTrials.gov ID
- NCT07095205
- Acronym / sponsor ID
- VATMDDNicotine / IRB2023-00490
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: PET Scan with [18F] VATThis arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer [18F] VAT to measure cholinergic terminal density. |
| Major Depressive Disorder (MDD) | Experimental | Drug: Nicotine transdermal patch, Drug: PET Scan with [18F] VATThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine transdermal patchAlso: Nicorette NicoDerm CQ, Nicotine patchThe 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 | Major Depressive Disorder (MDD) |
| PET Scan with [18F] VATAll 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. | Drug | Control, Major Depressive Disorder (MDD) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramin Parsey, MD, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine transdermal patch and PET Scan with [18F] VAT in people with Major Depressive Disorder (MDD), run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julianna Lizzul (631-638-0291, julianna.lizzul@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-17 (HAMD) score. (time frame: Before and after 8 days of treatment with nicotine.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.