Depressed Mood Improvement Through Nicotine Dosing 3 (DepMIND3)
Depressive Disorder
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring geriatrics, aging, elderly, cognition, memory, nicotine transdermal patch, depression
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 years; diagnosis of major depressive disorder, single or recurrent episode (DSM5); On a stable therapeutic dose of an allowed SSRI or SNRI for at least 6 weeks; severity: at least mild active depression symptoms, defined as MADRS ≥ 15; cognition: MMSE ≥ 24; fluent in English Exclusion Criteria: Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) or social phobia symptoms occurring in a depressive episode; Use of other augmentation medication treatments for depression (e.g., adjunctive bupropion or other augmenting agents) that the participant does not want to stop, although short-acting sedatives are allowed; Any use of tobacco or nicotine in the last year. Living with a smoker or regular exposure to secondhand smoke. 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. Acute suicidality. Acute grief (<1 month); Current or past psychosis. Primary central nervous system neurological disorder, including dementia, stroke, epilepsy, etc.; Presence of unstable medical illness requiring urgent treatment or intervention; MRI contraindication. Electroconvulsive therapy or transcranial magnetic stimulation in last 2 months; Current or planned psychotherapy where the potential participant does not want to pause therapy for the duration of the study; Allergy or hypersensitivity to nicotine patches; In the last 4 weeks, regular use of drugs with central cholinergic or anticholinergic properties or moderate / severe CYP2A6 inhibitors /inducers
Sites / Locations
- Vanderbilt Psychiatric HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Transdermal Nicotine Patch
Transdermal Placebo Patch
Participants will be randomized to apply nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 7mg in the first 3 weeks. Doses can be optionally titrated to a maximum of 14mg over 12 weeks, based on tolerability and perceived benefit. After 12 weeks, the patch dose will be tapered over 2-3 weeks.
Participants will be randomized to apply placebo transdermal patches during waking hours. Placebo patch titration will mirror the active arm, increasing the dose will titrate up from 3.5mg to 7mg in the first 3 weeks. Doses can be optionally titrated to a maximum of 14mg over 12 weeks, based on tolerability and perceived benefit. After 12 weeks, the patch dose will be tapered over 2-3 weeks.