Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension

What Was Tested

The trial (phase 2) is built around 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 1 arm (groups): Transdermal Nicotine Patch (experimental).

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 an open-label extension of a randomized double blind placebo control trial that will enroll 80 participants over a 3-year period.

After randomization and completion of the blinded study phase, participants will be eligible for this 12-week extension.

Who Took Part

Enrollment: 25 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;. Fluent in English.

The full record lists 6 inclusion and 14 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

Design: single-group and open-label.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

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 basic science.

What Was Measured

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

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 trial of Therapeutic nicotine (patch, non-peptide) in 25 people.

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

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.