Depressed Mood Improvement Through Nicotine Dosing 3
NCT05746273, Phase 2, Completed, Vanderbilt University Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Depressed Mood Improvement Through Nicotine Dosing 3 | ClinicalTrials.gov |
| NCT number | NCT05746273 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 40 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vanderbilt University Medical Center | ClinicalTrials.gov |
| Conditions | Depressive Disorder | ClinicalTrials.gov |
| Interventions | Transdermal Nicotine Patch, Transdermal Placebo Patch | ClinicalTrials.gov |
| First posted | 2023-02-27 | ClinicalTrials.gov |
| Last updated | 2026-08-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | MADRS (Montgomery Asberg Depression Rating Scale) Score | Baseline to week 12 | Primary mood outcome measured by the total score of the clinician rated MADRS. MADRS will be measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity. | ClinicalTrials.gov |
| Primary | Functional Magnetic Resonance Imaging (MRI) | Baseline to week 6. | MRI scans will be performed at baseline and week 6. MRI will measure cognitive control network function, operationalized as a reduction in the Stroop BOLD response in the middle and superior frontal gyri. The Stroop BOLD response is calculated as the activation difference between incongruent and congruent conditions of the emotional Stroop task. The primary outcome will be change in activation difference from baseline to week 6. This will be examined as both a continuous variable and a categorical variable, operationalized as those subjects will exhibit a middle / superior frontal gyri z-score reduction in activation over time of 0.5 or greater. | ClinicalTrials.gov |
| Secondary | NIH EXAMINER Test Battery | Baseline to Week 12 | Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. We will examine its Executive Composite Score and the three factor scores (Cognitive Control, Fluency, and Working Memory). Higher scores indicate better performance. | ClinicalTrials.gov |
| Secondary | Selective Reminding Task | Baseline to Week 12 | Secondary cognitive outcome, Selective Reminding Task as a test of immediate and delayed verbal memory. This is an 8-trial, 16-word test where the interviewer reads unrelated words to the participant who must recall them. Any missed items are then repeated before the next attempt. Alternative word lists are available for repeated assessments. A delayed trial is administered after 20 minutes. Change in the recall, failure to recall and consistency over 12 weeks reflect the verbal memory function. | ClinicalTrials.gov |
| Secondary | Trait Adjectives Task | Baseline to Week 12 | Participants view a series of randomized, rapidly presented positive and negative characteristics and quickly indicate whether each adjective does or does not apply to them. Positive and negative adjectives are balanced. Measures include number of adjectives endorsed or rejected, and RT for those trials. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Anticipate increased endorsement of positive adjective and increased rejection of negative adjectives in the active arm. | ClinicalTrials.gov |
| Secondary | Ruminative Response Scale | Baseline to Week 12 | Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at Screening visit, week 6 and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination. | ClinicalTrials.gov |
| Secondary | Apathy Evaluation Scale (AES) | Baseline to Week 12 | Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where lower scores indicate greater apathy. | ClinicalTrials.gov |
| Secondary | Insomnia Severity Index | Baseline to Week 12 | Secondary Mood Outcomes: Change in the severity of insomnia measures as self-report, a questionnaire with the range of 0-21, where higher scores indicate increase in severity. | ClinicalTrials.gov |
| Secondary | Penn State Worry Questionnaire (PSWQ) | Baseline to Week 12 | Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry. | ClinicalTrials.gov |
| Secondary | Fatigue Severity Scale | Baseline to Week 12 | Secondary fatigue out come :self-reported questionnaire that ranges from 0- 56;where higher scores indicate severe fatigue. | ClinicalTrials.gov |
| Secondary | General Anxiety Disorder Scale (7 Item) | Baseline to Week 12 | Secondary Mood outcome: self-reported questionnaire to measure the severity of anxiety. Questionnaire ranges 0-24, higher scores indicates greater anxiety state. | ClinicalTrials.gov |
| Secondary | PROMIS Applied Cognition Abilities Short | Baseline to Week 12 | Secondary Cognitive outcome:PROMIS (Patient reported outcome measurement information system) is a self-reported questionnaire to measure mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions, ranges from 0-32 , where higher scores indicate improvement. | ClinicalTrials.gov |
| Secondary | Attentional Control Scale | Baseline to Week 12 | Secondary Cognitive outcome: The Attentional Control Scale (ACS) is a self-report questionnaire that has been developed to measure individual differences in attentional control. These findings are discussed in relation to previous studies on attentional and executive control in anxiety and depression. Higher scores indicative of better attentional control. | ClinicalTrials.gov |
| Secondary | Monetary Incentive Delay Task | Baseline and to week 12 | Secondary cognitive outcome. This task assesses neural response during reward anticipation and receipt. On each trial, participants are presented with a cue indicating that trial's reward value ($0, $1, $2, or $4). After the cue, a delay period ensues as the participant waits for the target. Participants press a button as quickly as possible when the target is visible. A feedback screen then appears indicating the outcome ("Hit!" or "Miss!") for each trial, with a brief interval before the next trial. Target duration is continually adjusted during the session based on individual performance to keep success rate at 60%. Participants will complete trials over 15 minutes. | ClinicalTrials.gov |
| Secondary | Probabilistic Selection Task | Baseline and to week 12 | Secondary cognitive outcome to assess brain's reward system.Participants are instructed to choose between abstract stimuli via key press. The task is composed of two phases. During the first phase, subjects learn to associate 6 abstract visual stimuli with different reward probabilities. In phase 1, the various stimuli are always presented in pairs, where the sum of the two reward probabilities associated with each stimuli equal 100%. Participants learn that for each pair, choosing one stimuli over the other results in more reward. The subject is tested on this association in phase two. During phase two, the subject must decide between novel combinations of stimuli. Each stimuli is presented with the remaining four stimuli that it was not paired with in phase 1. Participants are instructed to win as many rewards as possible. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R33MH122464 | Nicotinic Modulation of the Cognitive Control System in Late-Life Depression | ANDREWS, PATRICIA SERRANO | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL INSTITUTE OF MENTAL HEALTH | 2023 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Monetary Incentive Delay | Secondary outcome | ConductCognition |
| Probabilistic Selection Task | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)