Your session is about to expire
← Back to Search
Nicotinic Acetylcholine Receptor Agonist
Nicotine Patch for Depression
Phase 2
Recruiting
Led By Warren D Taylor
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the effects of Transdermal Nicotine Patches on late-life depression symptoms, cognitive performance, and the Cognitive Control Network.
Who is the study for?
This trial is for people aged 60 or older with major depressive disorder, who have been on a stable dose of certain antidepressants for at least 8 weeks. They must score ≥15 on the MADRS and ≥24 on the MMSE, speak English fluently, and not use tobacco or nicotine in the past year. Exclusions include substance abuse disorders, recent acute grief, other psychiatric disorders except GAD within depression, MRI contraindications, allergy to nicotine patches, and living with smokers.
What is being tested?
The study tests if Transdermal Nicotine Patches can improve mood and cognitive performance in elderly individuals with depression by enhancing Cognitive Control Network function. It's an open-label extension of a previous blinded study where participants will receive up to 12 weeks of treatment followed by a safety follow-up.
What are the potential side effects?
Potential side effects from using Transdermal Nicotine Patches may include skin irritation at the patch site, dizziness, headache, nausea/vomiting; less commonly palpitations or changes in heart rate could occur due to nicotine's stimulating effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Continuous Performance Task (CPT) Performance
Change in MADRS (Montgomery Asberg Depression Rating Scale) Score
Secondary study objectives
Apathy Evaluation Scale (AES)
Attentional Control Scale
Fatigue Severity Scale
+8 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0443376745%
Skin reaction
17%
Dizziness
17%
Headache
17%
Nausea
10%
Insomnia
10%
Increased tension and inner restlessness
10%
Increased dream activity
3%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transdermal Nicotine Patch
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transdermal Nicotine PatchExperimental Treatment1 Intervention
Participants will wear nicotine transdermal patches daily for 12-15 weeks. Participants will apply a study patch each morning and remove at bedtime. Active dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.
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
908 Previous Clinical Trials
934,527 Total Patients Enrolled
17 Trials studying Depression
2,307 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,982 Total Patients Enrolled
706 Trials studying Depression
260,998 Patients Enrolled for Depression
Warren D TaylorPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used certain drugs affecting the brain or liver enzymes in the last month.I have a primary neurological disorder like dementia, stroke, or epilepsy.I have been diagnosed with major depression.I have a psychiatric condition, but it's not GAD within a depressive episode.I am taking medication for depression, but not short-acting sedatives.I haven't had electroconvulsive or magnetic brain therapy in the last 2 months.I am 60 years old or older.I have been on a steady dose of certain depression medications for at least 8 weeks.I am currently in or planning to start psychotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Transdermal Nicotine Patch
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.