CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Nicotinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02816138
NCT02816138Phase 4Completed

Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)

Vanderbilt University Medical Center·interventional·Posted Jun 28, 2016·Updated Sep 27, 2018

In Brief

A Phase 4 clinical trial evaluating Nicotine for Major Depressive Disorder. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Late-life depression is characterized by both affective (mood) symptoms and cognitive deficits. There is currently no intervention that may provide consistent benefits to both mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via transdermal nicotine patches may provide benefit to both mood and cognition, working through nicotine's effects on brain neural networks, specifically the cognitive control network and default mode network. In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking depressed elders with subjective cognitive impairment. Following baseline neuroimaging and cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine. Afterwards, participants will repeat neuroimaging and cognitive assessments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 28, 2016
Enrollment StartOct 1, 2016
Primary CompletionAug 23, 2017
Study CompletionSep 12, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.0 years ago

Interventions

Nicotinedrug

Open-label transdermal nicotine patch