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LPS Challenge for Depression
Study Summary
This trial is testing whether an inflammatory marker called Lipopolysaccharide-binding protein (LBP) is increased in people with major depressive disorder (MDD), and whether this is associated with a greater response to an anti-inflammatory medication.
- Depression
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 20 Patients • NCT02876601Trial Design
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- You have a mental condition called psychosis.You developed depression when you were older than 40 years.You are currently taking certain medications that could affect the study results.You have had a head injury in the past that caused you to lose consciousness.You have been diagnosed with bipolar disorder.You have other health conditions like rheumatoid arthritis or autoimmune disorders that cause inflammation.You have a strong fear of small, enclosed spaces.You are currently taking strong pain medications like opioids or have a history of addiction to pain medications.You have used methamphetamine at any point in your life.You have other health conditions like heart or brain problems, or chronic pain disorders.You have certain types of implants in your body, like pacemakers or aneurysm clips, that could be unsafe during the study.This is a general criterion that does not have any specific requirements.You have had serious thoughts about hurting yourself or attempting suicide in the past year.You have been using drugs or alcohol excessively in the past 6 months.Your body mass index (BMI) is greater than 35 because being overweight can increase inflammation in your body.Your heart rate is too slow (less than 50 beats per minute) or too fast (greater than 100 beats per minute).
- Group 1: High CRP LPS Intervention
- Group 2: Low CRP LPS Placebo
- Group 3: Low CRP LPS Intervention
- Group 4: High CRP LPS Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment allow for participants who are octogenarians?
"In order to be included in this particular study, potential participants must 18-55 years old. There are 206 other trials that cater to patients under the age of 18 and 1003 for those senior citizens who are 65+."
Are there any current openings for participants in this trial?
"That is correct, the study is still looking for patients. According to the clinicaltrials.gov website, the trial was originally posted on September 7th, 2017 and was last edited on August 30th, 2021. They are only recruiting at 1 site but need 100 participants in total."
Could I potentially qualify to participate in this clinical trial?
"This study is enrolling 100 patients, within the ages of 18 and 55 who have major depressive disorder (mdd). It is important that participants also meet the following criteria: Depressed participants will be required to be in good general health (as evaluated during Visit 1, including EKG) and to be 18-55 years of age. Depressed participants will be required to have symptoms of depression (i.e. a PHQ-9 score ≥10) and be unmedicated for at least 3 weeks (8 weeks for fluoxetine) or treated with only one anti-depressant medication. Half"
Has the FDA given their okay to Lipopolysaccharide?
"Although there is some data supporting Lipopolysaccharide's safety, it is a Phase 2 trial so none of the evidence collected thus far supports efficacy. Therefore, we have given it a score of 2."
How many participants are being accepted into this experiment?
"That is correct. The listed clinical trial on clinicaltrials.gov is currently seeking patients. This particular study was posted on September 7th, 2017 and updated as recently as August 30th, 2021. A total of 100 patients will be participating at the single location."
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