Major Depressive Disorder Clinical Trial
Official title:
Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
Verified date | August 2018 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 12, 2017 |
Est. primary completion date | August 23, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Psychiatric Hospital | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score | Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity. | Baseline to week 12 | |
Primary | Change in Continuous Performance Task (CPT) Performance | Primary cognitive outcome, the CPT is a neuropsychological test that measures attention. In this 14-minute test, participants are asked to respond when any letter appears, except the non-target letter "X". This test is conducted at baseline and at week 12. The specific primary outcome metric is standard error of change in the inter-stimulus hit reaction time, or variability between different trials. There is no absolute range, but lower scores indicate decreased variability across trials and overall better performance. | Baseline to week 12 | |
Secondary | Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score | Secondary mood outcome: Change in anhedonia measured by SHAPS, a self-report questionnaire that ranges from 0-42, where higher scores indicate greater anhedonia. | Baseline to week 12 | |
Secondary | Change in Penn State Worry Questionnaire (PSWQ) | Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry. | Baseline to week 12 | |
Secondary | Change in Ruminative Response Scale Total Score | Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at baseline and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination. | Baseline to week 12 | |
Secondary | Change in Apathy Evaluation Scale (AES) | Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where lower scores indicate greater apathy. | Baseline to 12 weeks | |
Secondary | Change in MFQ (Memory Frequency Questionnaire) Score | Secondary cognitive outcome: Change in subjective cognitive performance as measured by MFQ, a self-report scale ranging from 64-448. Higher scores indicate better subjective memory function, while lower scores indicate poorer subjective memory function. | Baseline to week 12 | |
Secondary | Change in Choice Reaction Time (CRT) Performance | Secondary cognitive outcome, a neuropsychological test measure of attention. We examined the total response time for the CRT. Lower scores indicate better performance. | Baseline to week 12 | |
Secondary | Change in One-back Test Performance | Secondary cognitive outcome examining change in speed of responses ton the one-back test, no absolute range. In this variant of the "N-back" task, participants view a series of cards, and indicate whether the card they are currently viewing is identical to the previously viewed card. Lower scores indicate better performance. | Baseline to week 12 | |
Secondary | Change in NYU (New York University) Paragraph Recall Performance | Secondary cognitive outcome of a neuropsychological test examining episodic memory performance using the NYU Paragraph Recall test. No absolute range. Higher scores indicate better performance. | Baseline to week 12 |
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