Depressed Mood Improvement Through Nicotine Dosing 3

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: 1. Age = 60 years; 2. diagnosis of major depressive disorder, single or recurrent episode (DSM5); 3. On a stable therapeutic dose of an allowed SSRI or SNRI for at least 6 weeks; 4. severity: at least mild active depression symptoms, defined as MADRS = 15; 5. cognition: MMSE = 24; 6. fluent in English Exclusion Criteria: 1. Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) or social phobia symptoms occurring in a depressive episode or diagnosis of an attentional disorder, such as Attention Deficit Hyperactivity Disorder (ADHD); 2. Use of other augmentation medication treatments for depression or ADHD e.g., stimulant medications (e.g., adjunctive bupropion or other augmenting agents) that the participant does not want to stop, although short-acting sedatives are allowed; 3. Any use of tobacco or nicotine in the last year. 4. Living with a smoker or regular exposure to secondhand smoke. 5. History of alcohol use disorder or substance use disorder of moderate or greater severity (endorsing 4 or more of the 12 criteria) in the last 12 months. 6. Acute suicidality. 7. Acute grief (<1 month); 8. Current or past psychosis. 9. Primary central nervous system neurological disorder, including dementia, stroke, epilepsy, etc.; 10. Presence of unstable medical illness requiring urgent treatment or intervention; 11. MRI contraindication. 12. Electroconvulsive therapy or transcranial magnetic stimulation in last 2 months; 13. Current or planned psychotherapy where the potential participant does not want to pause therapy for the duration of the study; 14. Allergy or hypersensitivity to nicotine patches; 15. In the last 4 weeks, regular use of drugs with central cholinergic or anticholinergic properties or moderate / severe CYP2A6 inhibitors /inducers

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MADRS (Montgomery Asberg Depression Rating Scale) Score;Functional Magnetic Resonance Imaging (MRI);Continuous Performance Task (CPT) Performance

Secondary Outcome Measures

Name	Time	Method
NIH EXAMINER Test Battery;Selective Reminding Task;Trait Adjectives Task;Ruminative Response Scale;Apathy Evaluation Scale (AES);Insomnia Severity Index;Penn State Worry Questionnaire (PSWQ);Fatigue Severity Scale;General Anxiety Disorder Scale (7 Item);PROMIS Applied Cognition Abilities Short;Attentional Control Scale