Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)

Completed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

Late-life depression is characterized by both affective (mood) symptoms and cognitive deficits. There is currently no intervention that may provide consistent benefits to both mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via transdermal nicotine patches may provide benefit to both mood and cognition, working through nicotine's effects on brain neural networks, specifically the cognitive control network and default mode network. In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking depressed elders with subjective cognitive impairment. Following baseline neuroimaging and cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine. Afterwards, participants will repeat neuroimaging and cognitive assessments.

Key facts

Study ID

NCT02816138

Run by

Vanderbilt University Medical Center

People needed

15

Starts

2016-10-01

Expected to finish

2017-09-12

Last updated by the study team

2018-09-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 60 years;
• DSM-5 (Diagnostic and statistical manual-5) diagnosis of major depressive disorder, single or recurrent episode;
• Subjective cognitive decline, defined as endorsing 20% of items on the Cognitive Complaint Index (CCI);
• depression severity: MADRS (Montgomery-Asberg Depression Rating Scale) ≥ 15;
• cognition: MOCA (Montreal Cognitive Assessment) ≥ 24;
• fluent in English;
• intact hearing / vision allowing completion of study procedures;
• for individuals on antidepressants at study entry, they must be on a stable dose for at least 6 weeks.

You may not qualify if…

• Other Axis I psychiatric disorders, except for anxiety symptoms occurring in a depressive episode;
• History of alcohol or drug dependence or abuse in the last 3 years;
• Tobacco or nicotine use in last year;
• History of a developmental disorder or IQ score < 70;
• Acute suicidality;
• Acute grief (<1 month);
• Current or past psychosis;
• Primary neurological disorder, including dementia, stroke, brain tumors, etc.;
• Any MRI contraindication;
• Unstable medical illness;
• Allergy or hypersensitivity to nicotine patches;
• Regular use of drugs with centrally acting cholinergic or anticholinergic properties in last 4 weeks, including acetylcholinesterase inhibitors;
• Current or planned psychotherapy;
• Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last two months.

Where it is running

• Vanderbilt Psychiatric Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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