Major Depressive Disorder (MDD)
Conditions
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.
Interventions
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).
DRUGPET 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.
Sponsors
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Stony Brook University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale-17 (HAMD) score. | 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. |
Countries
United States
Contacts
Primary ContactJulianna Lizzul
Outcome results
None listed