Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension - Trial NCT05746546
Access comprehensive clinical trial information for NCT05746546 through Pure Global AI's free database. This Phase 2 trial is sponsored by Vanderbilt University Medical Center and is currently Not yet 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
May 01, 2023
Oct 31, 2026
Primary Outcome
Change in MADRS (Montgomery Asberg Depression Rating Scale) Score,Change in 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 is an open-label, extension to the blinded Depressed MIND 3 (Depressed Mood Improvement
 through nicotine dosing) study. It will evaluate longer-term safety and efficacy of
 Transdermal Nicotine Patches for potential benefit in cognitive and depression outcomes in
 elderly depressed participants. Subjects complete blinded randomized trial of Depressed
 MIND-3 will be eligible for continuation in this extension. This extension study will consist
 of up to 12 weeks of treatment and a 3 -week safety follow-up period.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05746546
Non-Device Trial