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Could nicotine patches lift depression in seniors?

NCT ID NCT05746273

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests whether nicotine patches can improve cognitive control (like focus and memory) and mood in adults aged 60 and older with depression. Sixty participants will wear either a nicotine or placebo patch daily for 12-15 weeks. Researchers will measure changes in depression severity and brain activity using MRI scans and thinking tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nicotine patch
What this could lead to
If it works, this could point toward a new way to improve thinking and mood in older adults with depression.
What could go wrong
This is a small, early-phase trial with only 60 people. Nicotine is addictive and can have side effects like skin irritation or sleep problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Vanderbilt Psychiatric Hosptial

    Nashville, Tennessee, 37212, United States

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