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

Nicotinic Modulation of the Cognitive Control System in Late-Life Depression (R33 Phase)

This study is testing if nicotine patches can help improve mood and thinking skills in older adults with depression.

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: NCT05746273 on ClinicalTrials.gov

What this trial studies

This study investigates whether transdermal nicotine can enhance cognitive control and improve mood in older adults suffering from late-life depression. It is a randomized, double-blind, placebo-controlled trial involving 80 participants who will receive either active nicotine patches or placebo patches over a three-year period. The study aims to address cognitive deficits associated with depression, which are often resistant to standard antidepressant treatments. By targeting the cholinergic system, the research seeks to provide a novel therapeutic approach for improving both cognitive and emotional outcomes in this population.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older diagnosed with major depressive disorder who are stable on certain antidepressants.

Not a fit: Patients with other significant psychiatric disorders or those who have used nicotine in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new 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 improving cognitive function in similar populations, suggesting a promising avenue for further exploration.

Eligibility 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

Where this trial is running

Nashville, Tennessee

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

Study contacts

• Study coordinator: Patricia Andrews, MD

Conditions Depressive Disorder; geriatrics; aging; elderly; cognition; memory; nicotine transdermal patch; depression