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NCT02816138 · ClinicalTrials.gov registry record · Phase 4
Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT02816138: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT02816138 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02816138, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity.
Interventions
- DRUG Nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-09-12 |
| Phase | Phase 4 |
What the finished NCT02816138 record still lists
NCT02816138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Nicotine is the first listed.
NCT02816138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02816138 about?
NCT02816138 is a clinical study titled "Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)". 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 m...
What is the current status of trial NCT02816138?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2016-10. Estimated completion is 2017-09-12.
What interventions are being tested in trial NCT02816138?
The interventions under investigation include: Nicotine (DRUG).
Who is sponsoring clinical trial NCT02816138?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02816138's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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