RecruitingPhase 2NCT05746273

Depressed Mood Improvement Through Nicotine Dosing 3

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


Sponsor

Vanderbilt University Medical Center

Enrollment

60 participants

Start Date

Apr 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Deficits in cognitive control are core features of late-life depression (LLD), 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 Cognitive Control Network deficits in LLD. The study examines the hypothesis that nicotine acetylcholine receptor agonists enhance Cognitive Control Network function. This effect may resultantly improve mood and cognitive performance in LLD. Small, open-label studies of transdermal nicotine (TDN) patches have supported potential clinical benefit and provided support that transdermal nicotine administration engages the Cognitive Control Network. This blinded study will expand past open-label trials supporting potential benefit in LLD. It will examine TDN's effect on depression severity and cognitive control functions measured by neuropsychological testing. The study will evaluate 60 eligible and enrolled participants over a 3-year period.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a low-dose nicotine patch can improve depressive symptoms in older adults with depression who are already on an antidepressant but still not feeling well. Researchers think nicotine may have mood-boosting effects in the brain. **You may be eligible if...** - You are 60 years or older - You have a diagnosis of major depressive disorder - You are on a stable dose of an SSRI or SNRI antidepressant for at least 6 weeks - You still have at least mild depression symptoms - You have no significant memory or cognitive impairment - You are fluent in English - You have NOT used any tobacco or nicotine products in the past year **You may NOT be eligible if...** - You currently smoke or use nicotine, or live with a smoker - You have psychosis, bipolar disorder, dementia, stroke, or epilepsy - You have had ECT or TMS treatment in the past 2 months - You have acute suicidal thoughts - You have an MRI contraindication (e.g., metal implants) - You have moderate to severe alcohol or substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTransdermal Nicotine Patch

Participants will wear nicotine transdermal patches daily for 12-15 weeks. They will apply a study patch each morning and remove at bedtime. Active dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.

DRUGTransdermal Placebo Patch

Participants will wear placebo transdermal patches daily for 12-15 weeks. They will apply a study patch each morning and remove at bedtime. Placebo patch dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.


Locations(1)

Vanderbilt Psychiatric Hosptial

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05746273


Related Trials