Depressed Mood Improvement Through Nicotine Dosing 3 - Trial NCT05746273
Access comprehensive clinical trial information for NCT05746273 through Pure Global AI's free database. This Phase 2 trial is sponsored by Vanderbilt University Medical Center and is currently Recruiting. The study focuses on Depressive Disorder. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
Vanderbilt University Medical Center
Timeline & Enrollment
Phase 2
Apr 15, 2023
Oct 31, 2026
Primary Outcome
MADRS (Montgomery Asberg Depression Rating Scale) Score,Functional Magnetic Resonance Imaging (MRI),Continuous Performance Task (CPT) Performance
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05746273
Non-Device Trial