Open Label Extension Study of Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3)
Status:
Not yet recruiting
Trial end date:
2026-10-31
Target enrollment:
Participant gender:
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 whol 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.