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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 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.

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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.

Conditions Studied

Depressive Disorder

Interventions

  • DRUG Transdermal Nicotine Patch
  • DRUG Transdermal Placebo Patch

Study Locations (1)

Tennessee

  • Vanderbilt Psychiatric Hosptial - Nashville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-04-15
Est. Completion 2026-09-30
Phase Phase 2

Sponsor

Vanderbilt University Medical Center

677 total trials

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What the Registry Record Tells You About NCT05746273

The ClinicalTrials.gov registry entry for NCT05746273 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 330-participant average among 47 other Depressive Disorder trials with a reported enrollment target (82% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.