Depressed Mood Improvement Through Nicotine Dosing 3

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Depressed Mood Improvement Through Nicotine Dosing 3," is investigating whether a nicotine patch can help improve mood and thinking skills in older adults who are experiencing depression. Researchers believe that nicotine may enhance the brain's ability to manage emotions and focus, which can be especially challenging for people with late-life depression. The study will include 60 participants aged 60 and older who have been diagnosed with major depressive disorder and are currently on a stable dose of an approved antidepressant.

Participants in this study can expect to undergo evaluations over a three-year period, including tests to measure their mood and cognitive function. To join, individuals must have mild to moderate depression symptoms and be fluent in English, but they cannot have used tobacco or nicotine in the past year or have certain other psychiatric or medical conditions. This trial is an important step in exploring new ways to support older adults struggling with depression, especially since existing treatments often don't address cognitive challenges.

Gender

ALL

Eligibility criteria

• 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