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NCT05746273 · ClinicalTrials.gov registry record · Phase 2
Depressed Mood Improvement Through Nicotine Dosing 3
A Phase 2 study of Depressive Disorder, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05746273: Recruiting Phase 2 study of Depressive Disorder, sponsored by Vanderbilt University Medical Center.
NCT05746273 is a Phase 2 study of Depressive Disorder that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 60 participants, below the 330-participant average among 47 other Depressive Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05746273, a Phase 2 study of Depressive Disorder, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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. Clinically characterized as executive dysfunction, these deficits are associated with poor response to antidepressants and higher levels of disability. Improvement of cognitive control network (CCN) dysfunction may benefit both mood and cognitive performance, however no current pharmacotherapy improves Cognitive Control Network deficits in LLD. The study examines the hypothesis that nicotine acetylcholine receptor agonists enhance Cognitive Control Network function. This effect may resultantly improve mood and cognitive performance in LLD. Small, open-label studies of transdermal nicotine (TDN) patches have supported potential clinical benefit and provided support that transdermal nicotine administration engages the Cognitive Control Network. This blinded study will expand past open-label trials supporting potential benefit in LLD. It will examine TDN's effect on depression severity and cognitive control functions measured by neuropsychological testing. The study will evaluate 60 eligible and enrolled participants over a 3-year period.
Primary Outcome
Primary mood outcome measured by the total score of the clinician rated MADRS. MADRS will be 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.
Conditions Studied
Interventions
- DRUG Transdermal Nicotine Patch
- DRUG Transdermal Placebo Patch
Study Locations (1)
Tennessee
- Vanderbilt Psychiatric Hosptial - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-15 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What NCT05746273 shows while recruiting
NCT05746273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 330-participant average among 47 other Depressive Disorder trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Transdermal Nicotine Patch is the first listed.
NCT05746273 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05746273 about?
NCT05746273 is a clinical study titled "Depressed Mood Improvement Through Nicotine Dosing 3". 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. Clinically characterized as executive dysfunction, these deficits are associated with...
What is the current status of trial NCT05746273?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-04-15. Estimated completion is 2026-09-30.
What conditions does trial NCT05746273 study?
This clinical trial studies the following conditions: Depressive Disorder.
What interventions are being tested in trial NCT05746273?
The interventions under investigation include: Transdermal Nicotine Patch (DRUG), Transdermal Placebo Patch (DRUG).
Who is sponsoring clinical trial NCT05746273?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05746273 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05746273's enrollment target sits among peer trials
60 31st of 47 higher than 16 of 47 other Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder 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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