RECRUITING

Depressed Mood Improvement Through Nicotine Dosing 3

Conditions

Depressive Disorder geriatrics aging elderly cognition memory nicotine transdermal patch depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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

Quick Facts

Study Start:2023-04-15

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05746273

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.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sarah Siddiqi

CONTACT

6159368297

sarah.siddiqi@vumc.org

Carrie Williams

CONTACT

6159362162

carrie.e.williams@vumc.org

Principal Investigator

Warren Taylor

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt Psychiatric Hosptial

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Warren Taylor, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-15

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-04-15

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

geriatrics
aging
elderly
cognition
memory
nicotine transdermal patch
depression

Additional Relevant MeSH Terms

Depressive Disorder