Status:
COMPLETED
Depressed Mood Improvement Through Nicotine Dosing 2
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Depressive Disorder
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Deficits in cognitive control are core features of late-life depression, contributing both to emotion dysregulation and problems with inhibiting irrelevant information, conflict detection, and working...
Detailed Description
Late-life depression (LLD) is characterized both by affective symptoms and broad cognitive deficits. The co-occurrence of cognitive deficits in LLD, particularly executive dysfunction, is a clinically...
Eligibility Criteria
Inclusion
- Age \> 60 years;
- Diagnosis of major depressive disorder, single or recurrent episode (DSM5);
- On a stable therapeutic dose of an allowed selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 8 weeks;
- Severity: Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 15;
- Cognition: Mini-Mental State Examination (MMSE) score ≥ 24;
- Fluent in English
Exclusion
- Other Axis I psychiatric disorders, except for generalized anxiety disorder (GAD) symptoms occurring in a depressive episode;
- Use of other medications for depression, e.g., bupropion or augmenting agents, although short-acting sedatives are allowed (see below);
- 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 neurological disorder, including dementia, stroke, epilepsy, etc.;
- MRI contraindication;
- Electroconvulsive therapy or transcranial magnetic stimulation in last 2 months;
- Current or planned psychotherapy;
- 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.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04433767
Start Date
December 15 2020
End Date
October 7 2022
Last Update
December 6 2023
Active Locations (1)
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1
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212