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Nicotinic Acetylcholine Receptor Agonist

Nicotine Patch for Depression (DepMIND3 Trial)

Phase 2

Recruiting

Led By Warren 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

DepMIND3 Trial Summary

This trial will test if nicotine patches can improve late-life depression symptoms & cognitive control functions. 60 people over 3 yrs will be evaluated.

Who is the study for?

This trial is for people over 60 with mild depression who've been on a stable dose of certain antidepressants for at least 6 weeks. They must have decent memory function, speak English, and not use tobacco or nicotine products in the past year. Those with serious medical conditions, recent psychotherapy they don't want to pause, exposure to secondhand smoke, or substance abuse issues can't join.Check my eligibility

What is being tested?

The study tests if nicotine patches can improve mood and cognitive functions in older adults with depression by activating the Cognitive Control Network. It compares the effects of real nicotine patches against placebo (fake) patches in participants over three years through neuropsychological testing.See study design

What are the potential side effects?

Potential side effects from using transdermal nicotine patches may include skin irritation where the patch is applied, dizziness, headache, nausea, and sleep disturbances. Allergic reactions are also possible but less common.

DepMIND3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Continuous Performance Task (CPT) Performance

Functional Magnetic Resonance Imaging (MRI)

MADRS (Montgomery Asberg Depression Rating Scale) Score

Secondary outcome measures

Apathy Evaluation Scale (AES)

Attentional Control Scale

Choice Reaction Time (CRT) Performance

+9 more

Side effects data

From 2009 Phase 4 trial • 60 Patients • NCT00383747

Nausea

allergic reaction to peanuts

deterioration in mental state

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Non Smokers With Schizophrenia

Controls

DepMIND3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transdermal Nicotine PatchExperimental Treatment1 Intervention

Participants will be randomized to apply nicotine transdermal patches during waking hours. Active dose will titrate up from 3.5mg to 7mg in the first 3 weeks. Doses can be optionally titrated to a maximum of 14mg over 12 weeks, based on tolerability and perceived benefit. After 12 weeks, the patch dose will be tapered over 2-3 weeks.

Group II: Transdermal Placebo PatchPlacebo Group1 Intervention

Participants will be randomized to apply placebo transdermal patches during waking hours. Placebo patch titration will mirror the active arm, increasing the dose will titrate up from 3.5mg to 7mg in the first 3 weeks. Doses can be optionally titrated to a maximum of 14mg over 12 weeks, based on tolerability and perceived benefit. After 12 weeks, the patch dose will be tapered over 2-3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transdermal Nicotine Patch

2015

Completed Phase 4

~1080

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,133 Total Patients Enrolled

17 Trials studying Depression

914 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,649 Total Patients Enrolled

667 Trials studying Depression

251,584 Patients Enrolled for Depression

Warren TaylorPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Transdermal Nicotine Patch (Nicotinic Acetylcholine Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05746273 — Phase 2

Depression Research Study Groups: Transdermal Nicotine Patch, Transdermal Placebo Patch

Depression Clinical Trial 2023: Transdermal Nicotine Patch Highlights & Side Effects. Trial Name: NCT05746273 — Phase 2

Transdermal Nicotine Patch (Nicotinic Acetylcholine Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746273 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh participants being welcomed in this trial presently?

"The research hosted on clinicaltrials.gov shows that this trial has concluded participant recruitment; the study was initially listed on March 1st 2023 and was last updated February 14th 2023. However, 828 other trials are currently seeking volunteers at present."

Answered by AI

Has the Transdermal Nicotine Patch gained authorization from the FDA?

"Due to its Phase 2 status, transdermal nicotine patch is assessed as being moderately safe on a scale of 1-3. While there are some safety data available for this product, efficacy has yet to be established in any clinical trials."

Answered by AI

What is the primary purpose of this medical trial?

"The objective of this clinical trial, monitored from the Baseline to week 12 phase, is to analyze Functional Magnetic Resonance Imaging (fMRI). Secondary goals encompass Choice Reaction Time (CRT) Performance - an attention-testing neuropsychological exam which evaluates total response time; Selective Reminding Task - a 16-word test where participants have to remember unrelated words after 20 minutes and Trait Adjectives Task - in which patients assess whether positive or negative adjectives relate to them. We anticipate that active arm results will feature increased endorsement of positive adjective and heightened rejection of adverse descriptors while assessing self-referential negativity bias associated with"

Answered by AI