RECRUITING

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

Conditions

Depressive Disorder Geriatrics aging elderly cognition memory Transdermal Nicotine Patch depression

Quick Navigation

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 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.

Official Title

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

Quick Facts

Study Start:2023-04-15

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05746546

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 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.

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 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.

Contacts and Locations

Study Contact

Sarah Siddiqi

CONTACT

6159368297

sarah.siddiqi@vumc.org

Carrie Williams

CONTACT

(615)936-2162

carrie.e.williams@vumc.org

Principal Investigator

Warren D Taylor

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Warren D 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 Date2026-10-31

Study Record Updates

Study Start Date2023-04-15

Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

Geriatrics
aging
elderly
cognition
memory
Transdermal Nicotine Patch
depression

Additional Relevant MeSH Terms

Depressive Disorder