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Endotoxin for Late-Life Depression (SHARE-D Trial)

Phase 1
Recruiting
Research Sponsored by Michael Irwin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SHARE-D Trial Summary

This trial will study the effects of sleep deprivation and inflammation on depression in older adults.

Eligible Conditions
  • Late-Life Depression

SHARE-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depressed Mood Subscale of the Profile of Mood States (POMS)
Mental Depression
Secondary outcome measures
Effort Expenditure for Reward Task
Emotion Facial Recognition Task
Emotion Intensity Task
+5 more
Other outcome measures
Affective Disorders, Psychotic
Pain
Cognitive Processing
+23 more

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%
Febrile neutropenia
20%
Insomnia
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

SHARE-D Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EndotoxinExperimental Treatment1 Intervention
Endotoxin 0.8 ng/kg body weight
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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?

Michael Irwin, MDLead Sponsor

Frequently Asked Questions

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

Does the trial permit minors to participate?

"This clinical trial is recruiting participants aged between 60 and 80 years of age."

Answered by AI

What is the extent of participation in this medical research?

"Yes, the records hosted on clinicaltrials.gov prove that this research is actively recruiting. The trial was initially made available to the public on January 1st 2018 and has since been revised a few times; most recently in September 30th 2022. This study requires 160 participants from one location for completion."

Answered by AI

Are there open spots left for enrollees in this trial?

"This clinical trial, first posted on January 1st 2018, is currently enrolling volunteers. The most recent changes were made to the study information on September 30th 2022."

Answered by AI

Who meets the criteria to be eligible for participation in this experiment?

"This study is admitting 160 people aged between 60 and 80 who have melancholia. To be eligible, participants must demonstrate good overall health (confirmed during the phone and in-person baseline session). Additionally, half of these individuals should possess a diagnosis of insomnia disorder made through the Structured Clinical Interview for Diagnosis, Diagnostic Statistical Manual 5 or Duke Structured Interview for Sleep Disorders; while the other half will not have been identified as suffering from insomnia via any of those assessments."

Answered by AI

To what degree might exposure to Endotoxin be hazardous?

"There is only a limited amount of data demonstrating the safety and efficacy of Endotoxin, so it was assigned a score 1 on our internal scale."

Answered by AI

What objectives are the researchers striving to fulfill with this study?

"This 12-hour study's primary goal is to evaluate the depressive mood of participants using the POMS. Secondary objectives include assessing patients' Hamilton Depression Rating Scale, Emotion Intensity Task (utilizing facial emotion recognition software), and Reward Learning Task which gauges an individual's behavior modification in response to rewards. A trained interviewer will be assigning ratings for depressed mood, guiltiness, loss of interest etc., while a computerized probabilistic reward task aids in measuring participant's ability to respond based on incentives received."

Answered by AI
~22 spots leftby Apr 2025