Improving mood and cognition in older adults with depression using nicotine patches

Open Label Extension Study of Depressed Mood Improvement Through Nicotine (Depressed MIND3)

This study is testing if nicotine patches can help older adults with depression feel better and think more clearly over three years.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT05746546 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the long-term benefits and safety of transdermal nicotine patches in older adults suffering from late-life depression (LLD). It builds on previous findings that suggest nicotine may enhance cognitive control network function, potentially improving both mood and cognitive performance. Participants who have completed a prior blinded trial will receive nicotine patches over a three-year period to assess their effects on depressive symptoms and cognitive deficits. The study focuses on a population that often experiences significant disability and poor response to traditional antidepressants.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older who have completed a prior 12-week blinded trial for major depressive disorder.

Not a fit: Patients with other significant psychiatric disorders or those not willing to discontinue certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option that improves both mood and cognitive function in older adults with depression.

How similar studies have performed: Previous small studies have shown potential benefits of transdermal nicotine in enhancing cognitive function in similar populations, suggesting a promising avenue for further exploration.

Eligibility criteria

Only individuals who complete 12 weeks of the blinded Depressed MIND trial will be eligible for enrollment.

Eligibility criteria for the blinded phase includes:

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 8 weeks;
4. Severity: Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 15;
5. Cognition: Mini-Mental State Examination (MMSE) score ≥ 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 (see below);
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 neurological disorder, including dementia, stroke, epilepsy, etc.;
10. MRI contraindication;
11. Electroconvulsive therapy or transcranial magnetic stimulation in last 2 months;
12. Current or planned psychotherapy;
13. Allergy or hypersensitivity to nicotine patches;
14. In the last 4 weeks, regular use of drugs with central cholinergic or anticholinergic properties or moderate / severe CYP2A6 inhibitors /inducers.

Where this trial is running

Nashville, Tennessee

• Vanderbilt Psychiatric Hospital — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Warren D Taylor — Vanderbilt University Medical Center
• Study coordinator: Sarah Siddiqi

Conditions Depressive Disorder; Geriatrics; aging; elderly; cognition; memory; Transdermal Nicotine Patch; depression