Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension

Change in MADRS (Montgomery Asberg Depression Rating Scale) Score,Change in Continuous Performance Task (CPT) Performance

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.