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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Feb 14, 2023

Keywords

ClinConnect Summary

The Depressed MIND3 Extension study is looking at how nicotine patches might help improve mood and thinking skills in older adults with depression. Researchers believe that people with late-life depression often struggle with "cognitive control," which affects their ability to manage emotions and focus on important information. Previous studies have shown that nicotine patches could help with these issues, and this trial aims to see if using them for a longer period can provide lasting benefits.

To participate, individuals need to be at least 60 years old, diagnosed with major depressive disorder, and currently taking a stable dose of certain antidepressants. They must also have a specific level of depression severity and cognitive ability. If eligible, participants will continue with the nicotine patch treatment for up to 12 weeks, followed by a 3-week safety check. It's important to note that people with a history of substance use issues, certain psychiatric disorders, or who have recently used tobacco will not be able to join the study. This research could be an important step in finding new ways to support older adults struggling with depression.

Gender

ALL

Eligibility criteria

• • 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.