Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension

Description

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 is an open-label, extension to the blinded Depressed MIND 3 (Depressed Mood Improvement through nicotine dosing) study. It will evaluate longer-term safety and efficacy of Transdermal Nicotine Patches for potential benefit in cognitive and depression outcomes in elderly depressed participants. Subjects complete blinded randomized trial of Depressed MIND-3 will be eligible for continuation in this extension. This extension study will consist of up to 12 weeks of treatment and a 3 -week safety follow-up period.

Conditions

Depressive Disorder

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Study Overview

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Study Details

Study overview

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 is an open-label, extension to the blinded Depressed MIND 3 (Depressed Mood Improvement through nicotine dosing) study. It will evaluate longer-term safety and efficacy of Transdermal Nicotine Patches for potential benefit in cognitive and depression outcomes in elderly depressed participants. Subjects complete blinded randomized trial of Depressed MIND-3 will be eligible for continuation in this extension. This extension study will consist of up to 12 weeks of treatment and a 3 -week safety follow-up period.

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

Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension

Condition
Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt Psychiatric Hospital, Nashville, Tennessee, United States, 37212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Warren D Taylor, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2026-10-31