Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Nicotine
Intervention description: Open-label transdermal nicotine patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Geriatrics; Depression; Elderly; Cognition; Memory

Summary:

      Late-life depression is characterized by both affective (mood) symptoms and cognitive
      deficits. There is currently no intervention that may provide consistent benefits to both
      mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via
      transdermal nicotine patches may provide benefit to both mood and cognition, working through
      nicotine's effects on brain neural networks, specifically the cognitive control network and
      default mode network.

      In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking
      depressed elders with subjective cognitive impairment. Following baseline neuroimaging and
      cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine.
      Afterwards, participants will repeat neuroimaging and cognitive assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 60 years;

          -  DSM-5 (Diagnostic and statistical manual-5) diagnosis of major depressive disorder,
             single or recurrent episode;

          -  Subjective cognitive decline, defined as endorsing 20% of items on the Cognitive
             Complaint Index (CCI);

          -  depression severity: MADRS (Montgomery-Asberg Depression Rating Scale) ≥ 15;

          -  cognition: MOCA (Montreal Cognitive Assessment) ≥ 24;

          -  fluent in English;

          -  intact hearing / vision allowing completion of study procedures;

          -  for individuals on antidepressants at study entry, they must be on a stable dose for
             at least 6 weeks.

        Exclusion Criteria:

          -  Other Axis I psychiatric disorders, except for anxiety symptoms occurring in a
             depressive episode;

          -  History of alcohol or drug dependence or abuse in the last 3 years;

          -  Tobacco or nicotine use in last year;

          -  History of a developmental disorder or IQ score < 70;

          -  Acute suicidality;

          -  Acute grief (<1 month);

          -  Current or past psychosis;

          -  Primary neurological disorder, including dementia, stroke, brain tumors, etc.;

          -  Any MRI contraindication;

          -  Unstable medical illness;

          -  Allergy or hypersensitivity to nicotine patches;

          -  Regular use of drugs with centrally acting cholinergic or anticholinergic properties
             in last 4 weeks, including acetylcholinesterase inhibitors;

          -  Current or planned psychotherapy;

          -  Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last two
             months.