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

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): Control (experimental) and Major Depressive Disorder (MDD) (experimental).

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

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 14 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age range 18 to 65 years old. Capacity to consent (able to read, understand, and sign informed consent). 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.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: 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; current or lifetime history of a major psychiatric diagnosis.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2024-10-03 with completion listed for 2029-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hamilton Depression Rating Scale-17 (HAMD) score (time frame: Before and after 8 days of treatment with nicotine).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 14 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.