Last reviewed · How we verify

NCT03848715

Sleep and Healthy Aging Research on Depression for Younger Women

Completed Phase 1 Results posted Last updated 27 January 2026
What this trial tests

Phase 1 trial testing Endotoxin in Anhedonia in 40 participants. Completed in 22 July 2024.

Timeline
2 October 2019
Primary endpoint
22 July 2022
22 July 2024

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment40
Start date2 October 2019
Primary completion22 July 2022
Estimated completion22 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

Adults 25 to 44, female only, with Anhedonia or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Non-social (Monetary) Reward Response (Reward Learning and Sensitivity) Primary · Baseline and post-injection (2.25 hrs)

Implicit reward learning and sensitivity to monetary reward is assessed with the probabilistic reward task (PRT) a behavioral computer task; change in the magnitude of response bias from baseline to post-injection is the outcome measure. More positive response bias indicates a bias towards the more frequently reward stimuli (a better outcome); more negative response bias indicates a bias towards the less frequently reward stimuli (a worse outcome). This is not a standardized scale with minimum and maximum values. Response bias is calculated using a formula from signal detection theory and is a

Baseline (pre-injection) PRT TASK
GroupValue95% CI
Endotoxin.563± .292
Placebo.307± .409
Post-injection PRT TASK
GroupValue95% CI
Endotoxin.309± .478
Placebo.366± .460
Non-social (Monetary) Reward Response (Reward Motivation) Primary · Baseline and post-injection (2.1 hrs)

Motivation for monetary reward is assessed with a 10-minute version of the Effort Expenditure for Rewards Task (EEfRT), a behavioral computer task; change in the amount of hard trials chosen (relative to total trials) from baseline to post-injection is the outcome measure. The task is analyzed using generalized estimating equations (GEE) with a binary outcome; outcome values at each timepoint therefore range from 0 to 1, with higher numbers indicating higher motivation (a better outcome). The predictor for the GEE model is a time (coded as 0 and 1) by condition (coded as 0 and 1) interaction t

GroupValue95% CI
Endotoxin-.3597425-.6121048 – -.1073803
Placebo-.0876787-.2934619 – .1181044
Non-social (Monetary) Reward Response (Reward Sensitivity) Primary · Baseline and post-injection (2.1 hrs)

Sensitivity for monetary reward is assessed with a 10-minute version of the Effort Expenditure for Rewards Task (EEfRT) a behavioral computer task, tested as the strength of the association between increases in potential monetary reward for hard trials and selection of hard (vs) easy trials during the task. This is tested using generalized estimating equations, with condition (LPS vs. placebo) by time (pre vs post-injection) by reward magnitude (ranges from $1-$4.12) predicting hard (vs easy) trial choice. More positive values indicate higher reward sensitivity ( a better outcome), and lower v

GroupValue95% CI
Endotoxin-.0525937-.1125722 – .0073848
Placebo.0521303.0032571 – .1010036
General Social Reward Response (Reward Sensitivity Via Emotional Dot Probe) Primary · Baseline and post-injection (2.7 hrs)

Sensitivity to general social reward cues (i.e., response to positive emotional faces) assessed as positive attentional bias with an emotional dot probe task. Attentional bias is assessed by measuring reaction times to targets that appear in the same location as emotional (e.g., happy faces) versus neutral cues (e.g., neutral faces). Outcomes are change from baseline to post-injection in attentional bias towards positive vs neutral faces. Higher positive attentional bias scores indicate higher sensitivity to reward; negative attentional bias score indicate less sensitivity to reward. A score

GroupValue95% CI
Endotoxin11.85463± 18.61149
Placebo5.806407± 38.32138
General Social Reward Response (Reward Sensitivity Via Face Morphing Task) Primary · Baseline and post-injection (2.8 hrs)

Sensitivity to general social reward cues (i.e., response to positive emotional faces) assessed as positive emotion detection with a face morphing task. The outcome is the absolute change from baseline to post-injection in the percent of accurate responses. Higher accuracy is an indicator of higher sensitivity to reward and lower accuracy is an indicator of lower sensitivity to reward.

GroupValue95% CI
Endotoxin.0092593± .0190538
Placebo.0657895± .0185456
General Social Reward Response (Social Reward Motivation) Primary · Baseline and post-injection (2 hrs)

Motivation for general social reward is assessed via self-report; participants rate their desire to engage in 3 different activities, one of which is social, on a 1 (not at all) to 10 (extremely) Likert scale.; change in desire for the social activity from baseline to post-injection is the outcome variable. Higher values indicate higher motivation.

GroupValue95% CI
Endotoxin-2.94± 3.40
Placebo-.29± 1.65
Depressed Mood Subscale of the Profile of Mood States (POMS) Secondary · Hourly, from pre-injection (T0) to 9 hours later (T9)

The Depressed Mood Subscale of the POMS is a self-reported assessment of depressed mood in which subjects rate severity of depressed mood using a visual analog scale from 1 to 10 (10 being most severe). Each timepoint is scored and analyses examine the temporal profile of change with assessment every hour. The outcome reported below is the mean score at 2-hours post-injection, which is when the response to endotoxin is known to peak. Higher values indicate more depressive symptoms.

GroupValue95% CI
Endotoxin6.939871± 1.952918
Placebo2.680794± 1.762826

Sponsor's own description

Compelling evidence indicates inflammation plays a role in depression, but potential mechanisms linking inflammation to depression, such as dysregulated reward processing, are poorly understood. This study comprehensively evaluates effects of inflammation on reward across dimensions (e.g., anticipating versus receiving a reward) and types (e.g., money vs. smiling faces) in younger and older women. Characterizing how inflammation shapes the dynamic and multidimensional reward system, and how this may differ by age, may give insight into risk factors for depression and help identify critical points for intervention.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation-induced depressed mood and reward responsivity as a function of age in female adults: a randomized controlled trial of endotoxin.
    Boyle CC, Cho JH, Eisenberger NI, Olmstead R, et al · · 2025 · cited 2× · PMID 41298372 · DOI 10.1038/s41398-025-03752-2
  2. Consummatory deficits in close social reward predict inflammation-induced depressed mood.
    Boyle CC, Rahal D, Meinert J, Ko V, et al · · 2026 · PMID 41192236 · DOI 10.1016/j.psyneuen.2025.107673

Verify or expand the search:

Other trials of Endotoxin

Trials testing the same drug.

Other recruiting trials for Anhedonia

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03848715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing