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+2 More
Endotoxin - Biological
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This study is evaluating whether inflammation may be linked to depression.

See full description

Eligible Conditions

  • Anhedonia
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Endotoxin will improve 2 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Anhedonia. Measurement will happen over the course of Baseline and post-injection (approximately 2 hrs).

12 hours
Depressed Mood Subscale of the Profile of Mood States (POMS)
Day 14
Anticipatory and Consummatory Daily Reward Response
Baseline and post-injection (approximately 2 hrs)
Dopaminergic activity
General social reward response (reward sensitivity and motivation)
Non-social (monetary) reward response (reward motivation, learning, sensitivity)
Post-injection (approximately 2 hrs)
Close social reward response
post-injection (approximately 3 hrs)
Positive and negative emotion regulation capacity

Trial Safety

Safety Progress

1 of 3

Side Effects for

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

Trial Design

2 Treatment Groups

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

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Endotoxin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Endotoxin
Biological
Endotoxin 0.8 ng/kg body weight; 1 infusion
Placebo
Biological
same volume of 0.9% saline
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: 14 days (7 days pre-injection; 7 days post-injection).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 14 days (7 days pre-injection; 7 days post-injection). for reporting.

Who is running the study

Principal Investigator
C. B.
Chloe Boyle, MD PhD
University of California, Los Angeles

Closest Location

Norman Cousins Center for Psychoneuroimmunology, University of California, Los Angeles - Los Angeles, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants will be required to be in good general health (as evaluated during the phone and in-person baseline session)
Participants will be biologically female and premenopausal (as evaluated by self report).
Participants will 25-44 years of age.

Patient Q&A Section

What causes depression?

"Depression is complex by virtue of the diverse factors that appear to be involved. However, it seems that many of those factors converge with the brain stem and the hippocampus as these areas are compromised in depression." - Anonymous Online Contributor

Unverified Answer

What are the signs of depression?

"Signs of depression can be seen as depressive symptoms, but patients with depression also have different signs than the other patients with depression: psychometric signs. These can be measured from the PHQ-9 to determine depressive symptoms or, if the patient fulfills the criteria for a depression diagnosis according to the DSM-IV, the signs for obtaining a diagnosis of a major depression." - Anonymous Online Contributor

Unverified Answer

What is depression?

"Depressive symptoms are highly prevalent in older adults and are associated with multiple health conditions. Results from a recent clinical trial suggests that geriatric psychopharmacologic interventions could have a role in the management of depressive symptoms among older adults." - Anonymous Online Contributor

Unverified Answer

What are common treatments for depression?

"Depressed persons have unique treatment needs, so treatment may be adapted to each individual's specific needs. Some therapies and medications might work more effectively for men than women. It’s vital to realize that the treatments will work less effectively for elderly patients. Cognitive-behavioral approaches may help to improve mood, decrease worrying, change thoughts and behaviors that worsen depression. Cognitive restructuring and cognitive processing therapy are good options for depressed individuals, but more research is needed to confirm these findings.\n\n- A study of the prevalence of depression in adult men found about 20 percent have depression; the most common symptom was feeling overwhelmed or disappointed." - Anonymous Online Contributor

Unverified Answer

Can depression be cured?

"At present, there are no effective treatments for MDD that can be routinely recommended. However, a number of treatments do appear to be effective and their efficacy and tolerability are being evaluated in large clinical trials. Further research in this area will be required to determine the full potential of this and other emerging treatments." - Anonymous Online Contributor

Unverified Answer

How many people get depression a year in the United States?

"Rates of lifetime and new-episode depression are both high. Depression also increases with age to a peak at age 60, even in men whose disease burden is moderate. Depression is also not uncommon in men and women aged 45 to 59 (i.e., early adulthood). Given the long life-span and high disease burden for depression, screening people of late life is an important use of healthcare resources." - Anonymous Online Contributor

Unverified Answer

Does depression run in families?

"The current family history methods are insufficient to detect which individuals in a large first-degree pedigree are at-risk for depression. As the results of this study are limited to a sample of siblings with a narrow estimate of heritability, new technologies such as genome-wide association study (GWAS) will be more informative. Such approaches are being explored now and may allow identification of the molecular genetics of depression." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of endotoxin?

"Endotoxin is associated with various respiratory and systemic symptoms including headache, flushing, muscle spasm, nausea, anorexia, and tachycardia. These symptoms are associated with the acute phase response and may be treated with medications, such as acetaminophen. In patients with chronic dyspnea or chronic heart disease, endotoxin is associated with the development of bronchospasm and hypoxia." - Anonymous Online Contributor

Unverified Answer

What is the latest research for depression?

"The number of randomized controlled trials in the last ten years continues to increase. This has resulted in a broader understanding and management of depression. We can no longer assume that it is a homogenous disorder with a homogenous definition. I think an increasing body of evidence proves that there are different forms of depression and for each form of depression, there is potential for different treatment approaches\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving endotoxin?

"Given the large volume of literature on endotoxin and its effects on cellular components, the use of systemic LPS is justified in order to obtain an understanding of endotoxin’s direct or indirect effects on immune function." - Anonymous Online Contributor

Unverified Answer

How serious can depression be?

"When severe, it can be a deadly disease. The most harmful effects of depression are physical and mental. On top of that, it can interfere with your life and make it harder and harder to succeed. In a severe form, depression can even lead to the death of the patient." - Anonymous Online Contributor

Unverified Answer

Is endotoxin safe for people?

"Endotoxin is not more frequently detected in cerebrospinal versus spinal fluid after a lumbar epidural when compared with blood. There appears to be a relationship between endotoxemia, aseptic meningitis, and an abnormal CSF cell count, but no relationship between the presence and timing of lumbar epidural anesthesia and the presence of endotoxemia in the CSF." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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