Depressed Mood Improvement Through Nicotine Dosing 2
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Deficits in cognitive control are core features of late-life depression, 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 CCN deficits in LLD.
Supported by pilot data, Investigators propose that nicotine acetylcholine receptor agonists
enhance CCN function and resultantly improve mood and cognitive performance in late-life
depression. The objective of this initial R61-phase trial is to first determine whether
transdermal nicotine enhances CCN neural activity in an exposure-dependent fashion during an
emotional response inhibition task (the emotional Stroop task). Investigator's approach for
the R61 phase is to examine in 36 older adults with Major Depressive Disorder whether
transdermal nicotine patches enhance CCN activity over 12 weeks as measured during fMRI with
the emotional Stroop task while measuring nicotine and nicotine metabolite levels.
Transdermal nicotine has a mechanism of action that is distinct from current antidepressants,
potentially making it a potentially important antidepressant augmentation agent. If
hypotheses are correct, as patches are commercially available, this approach could be rapidly
moved into definitive studies and may have applicability to other psychiatric disorders
characterized by CCN dysfunction.