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Depressed Mood Improvement Through Nicotine Dosing 2

NCT04433767, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2023-12-06

Trial 12

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleDepressed Mood Improvement Through Nicotine Dosing 2ClinicalTrials.gov
NCT numberNCT04433767ClinicalTrials.gov
StatusCompletedClinicalTrials.gov
PhasesPhase 2ClinicalTrials.gov
Enrollment29 participants, actualClinicalTrials.gov
Lead sponsorVanderbilt University Medical CenterClinicalTrials.gov
ConditionsDepressive DisorderClinicalTrials.gov
InterventionsTransdermal Nicotine patchClinicalTrials.gov
First posted2020-06-16ClinicalTrials.gov
Last updated2023-12-06ClinicalTrials.gov
Results first posted2023-12-06ClinicalTrials.gov
Limitations and caveatsSmall, open-label study designClinicalTrials.gov

Registered outcomes 22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryMADRS (Montgomery Asberg Depression Rating Scale) Score ChangeBaseline 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. Change is calculated as the difference between week 12 and baseline.
ClinicalTrials.gov
PrimaryNumber of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Baseline, week 6, week 12
MRI scans will be performed at baseline, week 6 and week 12. MRI will measure cognitive control network function, operationalized as a reduction in the emotional Stroop task functional MRI response in the middle and superior frontal gyri. The Stroop functional MRI response is calculated as the activation difference between incongruent and congruent conditions of the emotional Stroop task. The primary outcome is change in activation difference across the three time points. This is examined as a categorical variable, operationalized as those subjects who exhibit a middle / superior frontal gyri z-score reduction in activation over time of 0.5 or greater, relative to baseline at either week 6 and/or week 12. The a priori threshold being tested was that 60% or more of participants would exhibit a z-score reduction of 0.5 or greater, examined separately in the left and right middle and superior frontal gyri.
ClinicalTrials.gov
SecondaryNIH EXAMINER Test Battery Executive Composite Score ChangeBaseline to week 12
Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Executive Composite Score is a single score that represents overall executive function performance across multiple individual neuropsychological tests, including the Dot counting test, the N-back test, the Flanker task, a continuous performance test, anti-saccades test, a set shifting test, and fluency tests. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This composite is generated separately from EXAMINER sub scales.
ClinicalTrials.gov
SecondaryNIH EXAMINER Test Battery Cognitive Control Factor ChangeBaseline to week 12
Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Cognitive Control Factor Score is a single score that represents cognitive control function performance across multiple individual neuropsychological tests, including the Flanker task, a continuous performance test, anti-saccades test, and a set shifting test. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores. 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
SecondaryNIH EXAMINER Test Battery Fluency Factor ChangeBaseline to week 12
Secondary Cognitive Outcome: This neuropsychological test battery assesses a range of executive functions. Its Fluency Factor Score is a single score that represents verbal fluency performance across phonemic and categorical fluency assessments. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores.
ClinicalTrials.gov
SecondaryNIH EXAMINER Test Battery Working Memory Factor ChangeBaseline to week 12
Secondary Cognitive Outcome: The EXAMINER test battery Working Memory Factor Score is a single score that represents working memory performance across multiple individual neuropsychological tests, including the Dot counting and n-back tests. Higher scores indicate better executive function, with a range of -3.0 to 3.0. This is calculated independently of the executive composite or other factor scores. 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
SecondaryChoice Reaction Time (CRT) Performance ChangeBaseline to week 12Secondary cognitive outcome, a neuropsychological test measure of attention. We will examine change in total reaction time for the CRT. Lower reaction time indicates better performance.ClinicalTrials.gov
SecondarySelective Reminding Task Performance ChangeBaseline to week12
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. Scores range from 0-60, with higher scores indicating better performance. Change in the recall over 12 weeks reflect the verbal memory function, with higher scores indicating better verbal memory performance.
ClinicalTrials.gov
SecondaryTrait Adjectives Task, Change in Positive Items EndorsedAssessed at baseline, week 6, and week 12, change from baseline to week 12 reported
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. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. Scores for positive items endorsed range from 0 to 24, with higher scores indicating more positive items being endorsed, so a reduction in negativity bias.
ClinicalTrials.gov
SecondaryTrait Adjectives Task, Change in Negative Items RejectedAssessed at baseline, week 6, and week 12, change from baseline to week 12 reported
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. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. Scores for negative items rejected range from 0 to 24, with higher scores indicating that more negative items are rejected, thus a reduction in negativity bias.
ClinicalTrials.gov
SecondaryTrait Adjectives Task, Change in Reaction Time to Endorse Positive ItemsAssessed at baseline, week 6, and week 12, change from baseline to week 12 reported
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. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. A score reduction represents increased reaction time.
ClinicalTrials.gov
SecondaryTrait Adjectives Task, Change in Reaction Time to Reject Negative ItemsAssessed at baseline, week 6, and week 12, change from baseline to week 12 reported
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. These are assessed separately for positive items endorsed and negative items rejected. Task performance assesses self-referential negativity bias and is associated with antidepressant response. Task completed at baseline, week 6, and week 12. A reduction in score indicates a faster reaction time.
ClinicalTrials.gov
SecondaryRuminative Response Scale Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
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
SecondaryApathy Evaluation Scale (AES) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where higher scores indicate greater apathy. Measured at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryInsomnia Severity Index Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
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. Assessed at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryPenn State Worry Questionnaire (PSWQ) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
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. Assessed at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryFatigue Severity Scale Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
Secondary outcome examining fatigue using a self-report questionnaire that ranges from 0- 56, where higher scores indicate more severe fatigue. Questionnaire administered at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryDimensional Anhedonia Rating Scale (DARS) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
Secondary mood outcome: Change in anhedonia measured by DARS, a self-report questionnaire that ranges from 0-68, where lower scores indicate greater anhedonia. Conversely, higher scores indicate greater ability to enjoy activities. Assessed at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryGeneral Anxiety Disorder-7 Item Scale (GAD7) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
Secondary Mood outcome: self-reported questionnaire to measure the severity of anxiety. Questionnaire ranges 0-24, higher scores indicates greater anxiety state. Assessed at baseline, week 6, and week 12.
ClinicalTrials.gov
SecondaryPatient Reported Outcome Measurement Information System (PROMIS) Applied Cognition Abilities Short Form Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.
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. Assessed at baseline, week 6, and week 12.
ClinicalTrials.gov

Outcomes 22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource
PRIMARYMADRS (Montgomery Asberg Depression Rating Scale) Score ChangeBaseline to week 12Includes 29 participants randomized, 28 of whom completed all 12 weeks and 1 completed through week 6.units on a scaleMEANClinicalTrials.gov
PRIMARYNumber of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Baseline, week 6, week 12Includes 29 participants randomized, 28 of whom completed all 12 weeks and 1 completed through week 6.ParticipantsCOUNT_OF_PARTICIPANTSClinicalTrials.gov
SECONDARYNIH EXAMINER Test Battery Executive Composite Score ChangeBaseline to week 12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYNIH EXAMINER Test Battery Cognitive Control Factor ChangeBaseline to week 12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYNIH EXAMINER Test Battery Fluency Factor ChangeBaseline to week 12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYNIH EXAMINER Test Battery Working Memory Factor ChangeBaseline to week 12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYChoice Reaction Time (CRT) Performance ChangeBaseline to week 12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.MillisecondsMEANClinicalTrials.gov
SECONDARYSelective Reminding Task Performance ChangeBaseline to week12Analyses includes 28 randomized participants as 1 participant withdrew at week 6 so did not complete end of study assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYTrait Adjectives Task, Change in Positive Items EndorsedAssessed at baseline, week 6, and week 12, change from baseline to week 12 reportedAnalyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYTrait Adjectives Task, Change in Negative Items RejectedAssessed at baseline, week 6, and week 12, change from baseline to week 12 reportedAnalyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.units on a scaleMEANClinicalTrials.gov
SECONDARYTrait Adjectives Task, Change in Reaction Time to Endorse Positive ItemsAssessed at baseline, week 6, and week 12, change from baseline to week 12 reportedAnalyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.millisecondsMEANClinicalTrials.gov
SECONDARYTrait Adjectives Task, Change in Reaction Time to Reject Negative ItemsAssessed at baseline, week 6, and week 12, change from baseline to week 12 reportedAnalyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.millisecondsMEANClinicalTrials.gov
SECONDARYRuminative Response Scale Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYApathy Evaluation Scale (AES) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYInsomnia Severity Index Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYPenn State Worry Questionnaire (PSWQ) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYFatigue Severity Scale Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.29 participants analyzed, although one participant withdrew at week 6 before trial completion.score on a scaleMEANClinicalTrials.gov
SECONDARYDimensional Anhedonia Rating Scale (DARS) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYGeneral Anxiety Disorder-7 Item Scale (GAD7) Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov
SECONDARYPatient Reported Outcome Measurement Information System (PROMIS) Applied Cognition Abilities Short Form Score ChangeAssessed at baseline, week 6, and week 12; only change in baseline to week 12 reported.Analyses includes 29 randomized participant, however 1 participant withdrew at week 6 so did not complete 12 week assessments.score on a scaleMEANClinicalTrials.gov

Results by group 25

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource
MADRS (Montgomery Asberg Depression Rating Scale) Score ChangeTransdermal Nicotine Patch-15.4Standard Deviation 6.7units on a scaleClinicalTrials.gov
Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Transdermal Nicotine PatchLeft Middle Frontal Gyrus, total region18ParticipantsClinicalTrials.gov
Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Transdermal Nicotine PatchLeft Superior Frontal Gyrus, Total region16ParticipantsClinicalTrials.gov
Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Transdermal Nicotine PatchRight Middle Frontal Gyrus, total region17ParticipantsClinicalTrials.gov
Number of Participants Exhibiting Reduction in Frontal Activation During the Emotional Stroop Task During Functional Magnetic Resonance Imaging (MRI)Transdermal Nicotine PatchRight Superior Frontal Gyrus, total region10ParticipantsClinicalTrials.gov
NIH EXAMINER Test Battery Executive Composite Score ChangeTransdermal Nicotine Patch0.16Standard Deviation 0.31units on a scaleClinicalTrials.gov
NIH EXAMINER Test Battery Cognitive Control Factor ChangeTransdermal Nicotine Patch0.29Standard Deviation 0.50units on a scaleClinicalTrials.gov
NIH EXAMINER Test Battery Fluency Factor ChangeTransdermal Nicotine Patch0.18Standard Deviation 0.52units on a scaleClinicalTrials.gov
NIH EXAMINER Test Battery Working Memory Factor ChangeTransdermal Nicotine Patch0.05Standard Deviation 0.69units on a scaleClinicalTrials.gov
Choice Reaction Time (CRT) Performance ChangeTransdermal Nicotine Patch-0.67Standard Deviation 123.40MillisecondsClinicalTrials.gov
Selective Reminding Task Performance ChangeTransdermal Nicotine Patch0.33Standard Deviation 16.61units on a scaleClinicalTrials.gov
Trait Adjectives Task, Change in Positive Items EndorsedTransdermal Nicotine Patch2.28Standard Deviation 5.55units on a scaleClinicalTrials.gov
Trait Adjectives Task, Change in Negative Items RejectedTransdermal Nicotine Patch1.92Standard Deviation 4.87units on a scaleClinicalTrials.gov
Trait Adjectives Task, Change in Reaction Time to Endorse Positive ItemsTransdermal Nicotine Patch-120.99Standard Deviation 228.89millisecondsClinicalTrials.gov
Trait Adjectives Task, Change in Reaction Time to Reject Negative ItemsTransdermal Nicotine Patch-149.20Standard Deviation 252.25millisecondsClinicalTrials.gov
Ruminative Response Scale Score ChangeTransdermal Nicotine Patch-7.32Standard Deviation 12.27score on a scaleClinicalTrials.gov
Apathy Evaluation Scale (AES) Score ChangeTransdermal Nicotine Patch-7.36Standard Deviation 8.91score on a scaleClinicalTrials.gov
Insomnia Severity Index Score ChangeTransdermal Nicotine Patch-4.50Standard Deviation 7.36score on a scaleClinicalTrials.gov
Penn State Worry Questionnaire (PSWQ) Score ChangeTransdermal Nicotine Patch-5.07Standard Deviation 22.39score on a scaleClinicalTrials.gov
Fatigue Severity Scale Score ChangeTransdermal Nicotine Patch-3.15Standard Deviation 14.0score on a scaleClinicalTrials.gov

Participant flow 3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource
Overall StudySTARTEDTransdermal Nicotine Patch29ClinicalTrials.gov
Overall StudyCOMPLETEDTransdermal Nicotine Patch28ClinicalTrials.gov
Overall StudyNOT COMPLETEDTransdermal Nicotine Patch1ClinicalTrials.gov

Adverse events 8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource
otherSkin reactionSkin and subcutaneous tissue disordersTransdermal Nicotine Patch1329ClinicalTrials.gov
otherDizzinessNervous system disordersTransdermal Nicotine Patch529ClinicalTrials.gov
otherHeadacheNervous system disordersTransdermal Nicotine Patch529ClinicalTrials.gov
otherNauseaGastrointestinal disordersTransdermal Nicotine Patch529ClinicalTrials.gov
otherIncreased tension and inner restlessnessPsychiatric disordersTransdermal Nicotine Patch329ClinicalTrials.gov
otherInsomniaNervous system disordersTransdermal Nicotine Patch329ClinicalTrials.gov
otherIncreased dream activityNervous system disordersTransdermal Nicotine Patch329ClinicalTrials.gov
seriousFallInjury, poisoning and procedural complicationsTransdermal Nicotine Patch1291ClinicalTrials.gov

Adverse event totals 3

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource
Total, all-cause mortalityTransdermal Nicotine Patch029ClinicalTrials.gov
Total, other adverse eventsTransdermal Nicotine Patch2629ClinicalTrials.gov
Total, serious adverse eventsTransdermal Nicotine Patch129ClinicalTrials.gov

Papers 7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
19001356BACKGROUNDPubMed
22425432BACKGROUNDPubMed
25251617BACKGROUNDPubMed
25662104BACKGROUNDPubMed
28859996BACKGROUNDPubMed
30192444BACKGROUNDPubMed
39009312DERIVEDPubMed

Grants 0

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 10

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Emotional Stroop TaskPrimary outcomeConductCognition
Stroop Color-Word TestPrimary outcomeConductCognition
1-Back TaskSecondary outcomeConductCognition
2-Back TaskSecondary outcomeConductCognition
Antisaccade TaskSecondary outcomeConductCognition
Choice Reaction TimeSecondary outcomeConductCognition
Continuous Performance TestSecondary outcomeConductCognition
Eriksen Flanker TaskSecondary outcomeConductCognition
Selective Reminding TaskSecondary outcomeConductCognition
Verbal FluencySecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

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)