Depressed Mood Improvement Through Nicotine Dosing 3

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

Deficits in cognitive control are core features of late-life depression (LLD), contributing both to emotion dysregulation and problems with inhibiting irrelevant information, conflict detection, and working memory.

It had two arms (groups): Transdermal Nicotine Patch (experimental) and Transdermal Placebo Patch (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This may be particularly relevant in LLD, which is characterized both by affective symptoms and broad cognitive deficits.

Despite the clinical importance of cognitive deficits in LLD, there are no established treatments that specifically target cognition in this population.

The study is a randomized double blind placebo control trial that will enroll 80 participants over a 3-year period.

Participants will be randomized (2:1) to receive either active transdermal nicotine (TDN) patches or matching placebo patches.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 60 years;. Diagnosis of major depressive disorder, single or recurrent episode (DSM5);. Severity: at least mild active depression symptoms, defined as MADRS ≥ 15;. Cognition: MMSE ≥ 24;. Fluent in English.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: any use of tobacco or nicotine in the last year; living with a smoker or regular exposure to secondhand smoke; acute suicidality.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-04-15 with completion listed for 2026-07-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): MADRS (Montgomery Asberg Depression Rating Scale) Score (time frame: Baseline to week 12). Functional Magnetic Resonance Imaging (MRI) (time frame: Baseline to week 6).

It also tracked 13 secondary outcomes, for example NIH EXAMINER Test Battery, Selective Reminding Task, Trait Adjectives Task, Ruminative Response Scale, Apathy Evaluation Scale (AES) and Insomnia Severity Index.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 40 people.

The trial is marked completed; 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.