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Trial · NCT04309877

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryChange in depressed mood from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationShort Form of the Profile of Mood States (POMS-SF) Depression Subscale with higher scores indicating more severe depressed mood (range 0-32)
SecondaryChange in tension/anxiety from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationShort Form of the Profile of Mood States (POMS-SF) Tension Subscale with higher scores indicating more severe tension/anxiety (range 0-24)
SecondaryChange in depressive symptoms from baselineAt baseline and then at 2, 4, and 6 hours after LPS (or saline) administration
Montgomery-Asberg Depression Rating Scale (MADRS): a clinician-rated questionnaire of depressive symptoms with scores ranging from 0 to 60, with higher scores indicating more severe depressive symptoms
SecondaryChange in feelings of social disconnection from baselineAt baseline and then at 2, 4, and 6 hours after LPS (or saline) administration
Feelings of Social Disconnection Scale: a self-report questionnaire of feelings of social disconnection with scores ranging from 0 to 28, with higher scores indicating more severe feelings of social disconnection
SecondaryChange in fatigue from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationShort Form of the Profile of Mood States (POMS-SF) Fatigue Subscale with higher scores indicating more severe fatigue (range 0-20)
SecondaryChange in confusion from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationShort Form of the Profile of Mood States (POMS) Confusion Subscale with higher scores indicating more severe confusion (range 0-20)
SecondaryChange in verbal memory from baselineAt baseline and then 3 hours after LPS (or saline) administrationVerbal memory measured using computerized tests from CNS Vital Signs™
SecondaryChange in visual memory from baselineAt baseline and then 3 hours after LPS (or saline) administrationVisual memory measured using computerized tests from CNS Vital Signs™
SecondaryChange in executive function from baselineAt baseline and then 3 hours after LPS (or saline) administrationExecutive function measured using computerized tests from CNS Vital Signs™
SecondaryChange in attention from baselineAt baseline and then 3 hours after LPS (or saline) administrationAttention measured using computerized tests from CNS Vital Signs™
OtherSubjective Sensitivity to Social Rejection2 hours after LPS (or saline) administrationCyberball Social Exclusion Task
OtherNegative Bias in Facial Emotion Recognition2 hours after LPS (or saline) administrationEmotional Face Recognition Task
OtherReward2 hours after LPS (or saline) administrationReward Learning Task
OtherChange in proinflammatory cytokines from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationPlasma proinflammatory cytokines (interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-α, and soluble tumor necrosis factor receptor)
OtherChange in kynurenine Metabolites from baselineAt baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administrationPlasma tryptophan, kynurenine, quinolinic acid, and kynurenic acid
OtherChange in gene expression from baselineAt baseline and 30 minutes after LPS (or saline) administration
Genome-wide transcriptional profiling with focus on the percentage increase from baseline to 30 minutes after LPS (or saline) administration in activities of transcription factors related to immune activation, sympathetic activation, and glucocorticoid insensitivity: respectively, nuclear factor kappa-B (NF-kB), cAMP response element-binding protein (CREB), and glucocorticoid receptor (GR).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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