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Endotoxin for Depression

Phase 1
Waitlist Available
Led By Chloe C Boyle, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be 25-44 years of age
Participants will be biologically female and premenopausal (as evaluated by self report)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days (7 days pre-injection; 7 days post-injection).
Awards & highlights

Study Summary

This trial looks at how inflammation affects a person's ability to process rewards, which may give insight into risk factors for depression.

Who is the study for?
This trial is for premenopausal women aged 25-44 in good health, without chronic mental or physical illnesses, not taking certain medications like steroids or antidepressants, and who haven't worked night shifts or traveled across time zones recently. They should have no history of severe allergies, autoimmune diseases, fainting during blood draws, obesity (BMI > 35), drug use, or significant lab test abnormalities.Check my eligibility
What is being tested?
The study investigates how inflammation affects the reward system in younger women and its link to depression. It involves comparing the effects of an endotoxin (which can cause temporary inflammation) with a placebo on participants' responses to different rewards such as money or positive images.See study design
What are the potential side effects?
Potential side effects from the endotoxin may include flu-like symptoms such as fever, chills, headache, muscle pain and weakness due to induced inflammation. The placebo is unlikely to cause any direct side effects but could result in a reaction if there's an expectation of feeling unwell.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 44 years old.
Select...
I am a premenopausal woman.
Select...
I am between 25 and 44 years old.
Select...
I am a premenopausal woman.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days (7 days pre-injection; 7 days post-injection).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days (7 days pre-injection; 7 days post-injection). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
General social reward response (reward sensitivity and motivation)
Non-social (monetary) reward response (reward motivation, learning, sensitivity)
Secondary outcome measures
Anticipatory and Consummatory Daily Reward Response
Close social reward response
Mental Depression
+1 more
Other outcome measures
Positive and negative emotion regulation capacity

Side effects data

From 2016 Phase 1 & 2 trial • 10 Patients • NCT00923910
100%
Platelets-low
80%
Glucose, serum-low (hypoglycemia)
80%
Neutrophils/granulocytes (ANC/AGC) - low
80%
Rash/desquamation
80%
Leukocytes (total WBC) - low
80%
Pruritis/itching
80%
Hemoglobin-low
60%
AST, SGOT (serum glutamic oxaloacetic transaminase) - high
60%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
60%
Pain: Abdomen NOS
60%
Sodium, serum-low (hyponatremia)
60%
ALT, SGPT (serum glutamic pyruvic transaminase) - high
40%
Bicarbonate, serum low
40%
Albumin, serum low (hypoalbuminemia)
40%
Cough
40%
Magnesium, serum high (hypermagnesemia)
40%
Magnesium, serum low (hypomagnesemia)
40%
Nausea
40%
Potassium, serum-low (hypokalemia)
40%
Glucose (serum -high (hyperglycemia)
40%
Pain: Head/Headache
40%
Supraventricular and nodal arrhythmia: sinus tachycardia
40%
Mood alteration:anxiety
40%
Pain: throat/pharynx/larynx
40%
PTT (partial thromboplastin time)
40%
Calcium, serum-low (hypocalcemia)
40%
Diarrhea
20%
Insomnia
20%
Febrile neutropenia
20%
Hemorrhage, pulmonary/upper respiratory: Nose
20%
Hypotension
20%
Fatigue (asthenia, lethargy, malaise)
20%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
20%
Hepatobiliary/pancreas- Other, Specify - non-alcoholic Steatoheptits
20%
Infection with normal ANC or Grade 1 or 2 neutriphils:lung (pneumonia)
20%
GGT (gamma-Glutamyl transpeptidase)
20%
Dry eye syndrome
20%
Esophagitis
20%
Iron overload
20%
Ocular/Visual - Other, Specify - Eye drainage
20%
Pain: Eye
20%
Supraventricular and nodal arrhythmia: sinus bradycardia
20%
Pain:pain NOS
20%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Anorexia
20%
Allergy/Immunology - Other, Specify - allergy to Sorbaview
20%
Coagulation - Other, Specify - PT, prolonged
20%
Pain:Joint
20%
Rigors/chills
20%
Striae
20%
Sweating (diaphoresis)
20%
Triglyceride, serum high (hypertriglyceridemia)
20%
Uric acid, serum high (hyperuricemia)
20%
Urinary frequency/urgency
20%
Vision-blurred vision
20%
Potassium, serum-high (hyperkalemia)
20%
Phosphate, serum low (hypophosphatemia)
20%
Pain: chest wall
20%
Pain: neck
20%
Infection with normal ANC or Grade 1 or 2 neutrophils:lung (pneumonia)
20%
Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
20%
Pain:muscle
20%
Proteinuria
20%
Sodium, serum-high (hypernatremia)
20%
Infection with unknown ANC:sinus
20%
Bilirubin (hyperbilirubinemia)
20%
Cholesterol, serum-high (hypercholesteremia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recipients

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EndotoxinExperimental Treatment1 Intervention
Endotoxin 0.8 ng/kg body weight; 1 infusion
Group II: PlaceboPlacebo Group1 Intervention
same volume of 0.9% saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endotoxin
2008
Completed Phase 4
~500

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,811 Total Patients Enrolled
101 Trials studying Depression
48,403 Patients Enrolled for Depression
Chloe C Boyle, PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
57 Total Patients Enrolled
Michael R Irwin, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
403 Total Patients Enrolled
2 Trials studying Depression
403 Patients Enrolled for Depression

Media Library

Endotoxin Clinical Trial Eligibility Overview. Trial Name: NCT03848715 — Phase 1
Depression Research Study Groups: Placebo, Endotoxin
Depression Clinical Trial 2023: Endotoxin Highlights & Side Effects. Trial Name: NCT03848715 — Phase 1
Endotoxin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03848715 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of health risks does Endotoxin pose to humans?

"Per our assessment, Endotoxin's safety rate is 1 as this clinical trial has only been in Phase 1 with minimal data suggesting its efficacy and security."

Answered by AI

What is the purpose of this clinical experiment?

"As a primary measure, this trial is assessing the non-social reward response (motivational learning and sensitivity) over a baseline and post-injection time frame. Secondary objectives include investigating anticipatory and consummatory daily reward responses, close social rewards reactions, and dopaminergic activity levels. These outcomes are determined via visual analogue scales, verbal discussion of close others with reflective listening techniques, as well as changes in eye blink rate pre/post injection."

Answered by AI

Is this research endeavor accessible to patients at the present time?

"From the information on clinicaltrials.gov, it appears that this study is no longer seeking participants; its inaugural post being October 2nd 2019 and last update occurring July 11th 2022. Although not actively recruiting at present, there are other 1296 trials in need of patients."

Answered by AI

Does my profile meet the requirements for participation in this scientific investigation?

"This research seeks 40 participants suffering from anhedonia, aged 25 to 44. Eligibility criteria include self-reported premenopausal biological femininity and good general health as determined in the phone interview and baseline session."

Answered by AI

Does this medical experiment accept individuals aged 45 and over as participants?

"This specific medical experiment requires subjects aged between 25 and 44. Conversely, there are 193 trials for minors under 18 years old and 964 clinical studies geared towards elderly people above 65."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Sleep and Healthy Aging Research on Depression for Younger Women
Chloe Boyle, PhD 2019. "Sleep and Healthy Aging Research on Depression for Younger Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03848715.
All > Depression Los Angeles > Treatment Resistant Depression
~7 spots leftby Apr 2025
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