NCT05746273

Depressed Mood Improvement Through Nicotine Dosing 3

Name: Clinical Trial NCT05746273
Creator: Vanderbilt University Medical Center
Keywords: Depressive Disorder, Transdermal Nicotine Patch, Phase 2, drug, clinical trial, United States of America

Nicotinic Modulation of the Cognitive Control System in Late-Life Depression (R33 Phase)

Vanderbilt University Medical Center·Phase 2·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Depressive Disorder
Drug/Device/Intervention: Transdermal Nicotine Patch
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Vanderbilt University Medical Center
Location: Nashville, United States of America

Timeline & enrollment

Phase: Phase 2
Start date: Apr 15, 2023
End date: Oct 31, 2026
Enrollment: 60 participants

Primary outcome

MADRS (Montgomery Asberg Depression Rating Scale) Score,Functional Magnetic Resonance Imaging (MRI),Continuous Performance Task (CPT) Performance

Summary

Deficits in cognitive control are core features of late-life depression (LLD), contributing both to emotion dysregulation and problems with inhibiting irrelevant information, conflict detection, and working memory. Clinically characterized as executive dysfunction, these deficits are associated with poor response to antidepressants and higher levels of disability. Improvement of cognitive control network (CCN) dysfunction may benefit both mood and cognitive performance, however no current pharmacotherapy improves Cognitive Control Network deficits in LLD.  The study examines the hypothesis that nicotine acetylcholine receptor agonists enhance Cognitive Control Network function. This effect may resultantly improve mood and cognitive performance in LLD. Small, open-label studies of transdermal nicotine (TDN) patches have supported potential clinical benefit and provided support that transdermal nicotine administration engages the Cognitive Control Network.  This blinded study will expand past open-label trials supporting potential benefit in LLD. It will examine TDN's effect on depression severity and cognitive control functions measured by neuropsychological testing. The study will evaluate 60 eligible and enrolled participants over a 3-year period.

ICD-10 classifications

Depressive conduct disorderRecurrent depressive disorder, unspecifiedRecurrent depressive disorderOther recurrent depressive disordersRecurrent depressive disorder, currently in remission

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05746273
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05746273 through Pure Global AI's free database. This Phase 2 trial is sponsored by Vanderbilt University Medical Center and is currently Recruiting. The study focuses on Depressive Disorder. Target enrollment is 60 participants.

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