Depressed Mood Improvement Through Nicotine Dosing 2

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

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

It had 1 arm (groups): Transdermal Nicotine Patch (experimental).

The registry classes the interventions as drug.

More on the Plan

Late-life depression (LLD) 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.

This is particularly important, as the cognitive deficits appear to directly contribute to disability and poor antidepressant treatment outcomes.

Supporting this theory, nicotinic receptor activity stimulates serotonin release and protects against worsening mood with tryptophan depletion.

Who Took Part

29 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: Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 15;. Cognition: Mini-Mental State Examination (MMSE) score ≥ 24;. Fluent in English.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: other axis i psychiatric disorders, except for generalized anxiety disorder (gad) symptoms occurring in a depressive episode;; use of other medications for depression, e.g., bupropion or augmenting agents, although short-acting sedatives are allowed (see below);; any use of tobacco or nicotine in the last year;.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-12-15 with completion listed for 2022-10-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: MADRS (Montgomery Asberg Depression Rating Scale) Score Change (time frame: Baseline to week 12).

It also tracked 20 secondary outcomes, for example NIH EXAMINER Test Battery Executive Composite Score Change, NIH EXAMINER Test Battery Cognitive Control Factor Change, NIH EXAMINER Test Battery Fluency Factor Change, NIH EXAMINER Test Battery Working Memory Factor Change, Choice Reaction Time (CRT) Performance Change and Selective Reminding Task Performance Change.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 29 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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