Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Control
This arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer [18F] VAT to measure cholinergic terminal density.
  • 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.
Experimental
Major Depressive Disorder (MDD)
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.
  • 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).
    Other names:
    • Nicorette NicoDerm CQ
    • Nicotine patch
  • 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Stony Brook University

Study Contact

Julianna Lizzul
631-638-0291
julianna.lizzul@stonybrookmedicine.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.