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

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Stony Brook University
Study ID
NCT07095205
Phase
PHASE4
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Nicotine transdermal patch — DRUG
    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] VAT — DRUG
    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 Details

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.

Key Dates

Start date
Oct 3, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Hamilton Depression Rating Scale-17 (HAMD) score. [ Time Frame: Before and after 8 days of treatment with nicotine. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook University: Dept of PsychiatryStony BrookNew York11794
Julianna Lizzul
[email protected]
631-638-0291
Ramin Parsey, M.D., Ph.D.

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By research site
Stony Brook University: Dept of Psychiatry· Stony Brook, NY

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