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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

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuous Performance Task (CPT) Performance

Functional Magnetic Resonance Imaging (MRI)

MADRS (Montgomery Asberg Depression Rating Scale) Score

Secondary study objectives

Apathy Evaluation Scale (AES)

Attentional Control Scale

Fatigue Severity Scale

+8 more

Side effects data

From 2009 Phase 4 trial • 60 Patients • NCT00383747

Nausea

Vomiting

allergic reaction to peanuts

deterioration in mental state

100%

80%

60%

40%

20%

Study treatment Arm

Non Smokers With Schizophrenia

Controls

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

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