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Nicotinic Acetylcholine Receptor Agonist
Transdermal Nicotine patch for Depression (DepMIND2 Trial)
Phase 2
Waitlist Available
Led By Warren D Taylor, MD,MHSc
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 60 years;
Diagnosis of major depressive disorder, single or recurrent episode (DSM5);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, week 6, and week 12; only baseline to week 12 reported.
Awards & highlights
DepMIND2 Trial Summary
This trial is testing whether transdermal nicotine enhances cognitive control network (CCN) activity in older adults with Major Depressive Disorder, as measured by fMRI during an emotional response inhibition task.
DepMIND2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDepMIND2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, week 6, and week 12; only baseline to week 12 reported.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, week 6, and week 12; only baseline to week 12 reported.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MADRS (Montgomery Asberg Depression Rating Scale) Score Change
Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)
Secondary outcome measures
Anxiety Sensitivity Index 3 (ASI-3) Score Change
Apathy Evaluation Scale (AES) Score Change
Attentional Control Scale Score Change
+17 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0443376745%
Skin reaction
17%
Headache
17%
Nausea
17%
Dizziness
10%
Increased tension and inner restlessness
10%
Insomnia
10%
Increased dream activity
3%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transdermal Nicotine Patch
DepMIND2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Transdermal Nicotine PatchExperimental Treatment1 Intervention
Participants will wear open label transdermal nicotine patch daily for 12-15 weeks. They will apply study patch each morning and remove at bedtime. Dosage will begin at 3.5mg patch / day, increasing to a possible maximum of 21mg patch / day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transdermal Nicotine patch
2020
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
849 Previous Clinical Trials
669,008 Total Patients Enrolled
17 Trials studying Depression
914 Patients Enrolled for Depression
Warren D Taylor, MD,MHScPrincipal InvestigatorVanderbilt University Medical Center
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