Could nicotine patches lift depression in seniors?
NCT ID NCT05746546
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study looks at whether nicotine patches can safely improve mood and thinking in adults aged 60 and older with depression. Participants who completed a previous blinded trial will wear a patch daily for up to 12 weeks, then taper off. The goal is to see if nicotine helps the brain's control networks work better, easing depression symptoms.
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 treat depression in older adults by improving brain function.
- What could go wrong
- This is a small, open-label extension study with no placebo group, so results may be biased. Nicotine can be addictive and may cause 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
-
25 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 Hide 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.
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.
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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 Hospital
Nashville, Tennessee, 37212, United States
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