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

Stony Brook University

Status and phase: Enrolling; Phase 4

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: PET Scan with [18F] VAT; Drug: Nicotine transdermal patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07095205

1R21MH137546-01 (U.S. NIH Grant/Contract)

IRB2023-00490

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control

Experimental group

Description:

This arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer \[18F\] VAT to measure cholinergic terminal density.

Treatment:

Drug: PET Scan with [18F] VAT

Major Depressive Disorder (MDD)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine transdermal patch

Drug: PET Scan with [18F] VAT