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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

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

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 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT04433767

45%

Skin reaction

17%

Dizziness

17%

Headache

17%

Nausea

10%

Insomnia

10%

Increased tension and inner restlessness

10%

Increased dream activity

Fall

100%

80%

60%

40%

20%

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

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