Endotoxin for Anhedonia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles, CA
Anhedonia+5 More
Endotoxin - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will look at whether older adults with anxiety symptoms experience a loss of pleasure or motivation when exposed to inflammation. This will be evaluated using self-report questionnaires, computer tasks, and during a brain scan. Endotoxin is a treatment for Anhedonia that was previously approved by the FDA for a different condition. This treatment is free.

Eligible Conditions

  • Anhedonia
  • Depression
  • Inflammation
  • Anxiety
  • Aging

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anhedonia

Study Objectives

4 Primary · 11 Secondary · Reporting Duration: baseline and .5, 1, and 2 hours post-injection

10 hours
Depressed Mood Subscale of the Profile of Mood States (POMS)
Depressed mood and depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Motivation for social and non-social reward (interest in activities scale).
Systemic marker of inflammation as indexed by interleukin-6.
2 hours post-injection
Behavioral Indices of Reward motivation - close other social reward
Hour 2
Resting state functional connectivity
Hour 3
Attentional Bias Task
Emotion Intensity Task
Hour 4
Executive function - inhibition with the antisaccade task.
Executive function - shifting with color-shape task.
Executive function - updating with the spatial 2-back task
Hour 2
Behavioral Indices of Reward Sensitivity - EEfRT
Hour 2
Behavioral Indices of Reward Motivation - Effort-Based Decision Making
Behavioral Indices of Reward Sensitivity and Learning - Probabilistic Reward Task
Hour 2
Behavioral Indices of Reward Sensitivity - Positive Images Task
Neural Indices of Reward Sensitivity for Non-Monetary Reward
Hour 2
Behavioral Indices of Reward Motivation and Sensitivity with Incentive Delay Tasks
Neural Indices of Monetary Reward Sensitivity during Effort-Based Decision Making
Neural Indices of Reward Motivation - Effort-Based Decision Making
Hour 2
Monetary Incentive Delay Task -Neural Indices of Monetary Reward Sensitivity
Neural Indices of Reward Motivation - Anticipatory Reward Response
Social Incentive Delay Task - Neural Indices of Reward Motivation for Close Social Reward
Social Incentive Delay Task - Neural Indices of Reward Sensitivity for Close Social Reward
Social Incentive Delay Task - Neural Indices of Social Reward Motivation
Social Incentive Delay Task - Neural Indices of Social Reward Sensitivity
Hour 2
Genomic marker of inflammation

Trial Safety

Safety Progress

1 of 3

Other trials for Anhedonia

Side Effects for

Recipients
100%Platelets-low
80%Glucose, serum-low (hypoglycemia)
80%Neutrophils/granulocytes (ANC/AGC) - low
80%Hemoglobin-low
80%Leukocytes (total WBC) - low
80%Pruritis/itching
80%Rash/desquamation
60%Pain: Abdomen NOS
60%ALT, SGPT (serum glutamic pyruvic transaminase) - high
60%Sodium, serum-low (hyponatremia)
60%AST, SGOT (serum glutamic oxaloacetic transaminase) - high
60%Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
40%Cough
40%Magnesium, serum high (hypermagnesemia)
40%Diarrhea
40%Potassium, serum-low (hypokalemia)
40%PTT (partial thromboplastin time)
40%Pain: Head/Headache
40%Calcium, serum-low (hypocalcemia)
40%Albumin, serum low (hypoalbuminemia)
40%Supraventricular and nodal arrhythmia: sinus tachycardia
40%Pain: throat/pharynx/larynx
40%Bicarbonate, serum low
40%Mood alteration:anxiety
40%Glucose (serum -high (hyperglycemia)
40%Magnesium, serum low (hypomagnesemia)
40%Nausea
20%Striae
20%Anorexia
20%Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%Fatigue (asthenia, lethargy, malaise)
20%Coagulation - Other, Specify - PT, prolonged
20%Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%Pain:Joint
20%Rigors/chills
20%Bilirubin (hyperbilirubinemia)
20%Pain:pain NOS
20%Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%GGT (gamma-Glutamyl transpeptidase)
20%Febrile neutropenia
20%Pain: neck
20%Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%Sodium, serum-high (hypernatremia)
20%Esophagitis
20%Pain: Eye
20%Pain: chest wall
20%Hypotension
20%Iron overload
20%Insomnia
20%Dry eye syndrome
20%Ocular/Visual - Other, Specify - Eye drainage
20%Urinary frequency/urgency
20%Vision-blurred vision
20%Infection with unknown ANC:sinus
20%Sweating (diaphoresis)
20%Triglyceride, serum high (hypertriglyceridemia)
20%Potassium, serum-high (hyperkalemia)
20%Phosphate, serum low (hypophosphatemia)
20%Pain:muscle
20%Cholesterol, serum-high (hypercholesteremia)
20%Supraventricular and nodal arrhythmia: sinus bradycardia
20%Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%Uric acid, serum high (hyperuricemia)
20%Hemorrhage, pulmonary/upper respiratory: Nose
20%Proteinuria
This histogram enumerates side effects from a completed 2016 Phase 1 & 2 trial (NCT00923910) in the Recipients ARM group. Side effects include: Platelets-low with 100%, Glucose, serum-low (hypoglycemia) with 80%, Neutrophils/granulocytes (ANC/AGC) - low with 80%, Hemoglobin-low with 80%, Leukocytes (total WBC) - low with 80%.

Trial Design

2 Treatment Groups

Endotoxin
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Endotoxin · Has Placebo Group · Phase 1

Endotoxin
Biological
Experimental Group · 1 Intervention: Endotoxin · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endotoxin
2008
Completed Phase 4
~480

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and .5, 1, and 2 hours post-injection
Closest Location: Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Anhedonia
0 CompletedClinical Trials

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,382 Previous Clinical Trials
6,521,122 Total Patients Enrolled
6 Trials studying Anhedonia
635 Patients Enrolled for Anhedonia
National Institute on Aging (NIA)NIH
1,350 Previous Clinical Trials
3,324,471 Total Patients Enrolled
Chloe C Boyle, PHDPrincipal InvestigatorUniversity of California, Los Angeles

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.