BridgeMD
New treatment option for Major Depressive Disorder
Official title Neural Response to Inflammatory Challenge in Major Depressive Disorder
ClinicalTrials.gov ID: NCT04751331
What this study is testing
What is LPS?
LPS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a parallel group, double-blinded, placebo-controlled study. Participants with MDD (n=90) and HC (n=90) will be randomly assigned (2:1) to receive either lipopolysaccharide (LPS) (0.8ng/kg of body weight) or placebo (same volume of 0.9% saline) administered as an intravenous bolus.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Both healthy controls and depressed participants will be required to be in good general health (as evaluated during Visit 1, including EKG) and to be...
You likely can't join if
- General Exclusion Criteria:
- Pregnancy
- A history of fainting during blood draws will be evaluated by the clinical team and may be deemed exclusionary. Medical Conditions:
- Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with...
- Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological...
- Presence of co-morbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders.
See the full eligibility criteria
- Both healthy controls and depressed participants will be required to be in good general health (as evaluated during Visit 1, including EKG) and to be 18-65 years of age. A DSM-V diagnosis of MDD will be made with the...
- General Exclusion Criteria:
- Pregnancy
- A history of fainting during blood draws will be evaluated by the clinical team and may be deemed exclusionary. Medical Conditions:
- Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
- Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
- Presence of co-morbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders.
- Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.
- Presence of chronic infection that may elevate pro-inflammatory cytokines.
- Presence of an acute infectious illness or receipt of a vaccination in the two weeks prior to an experimental session. Psychiatric Disorders:
- Current severe suicidal ideation or attempt within the past 12 months.
- Psychosis
- Bipolar disorder
- Substance abuse or dependence within the previous 6 months Contraindications for MRI:
- Cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes...
- Claustrophobia that is severe enough to preclude MRI scanning. Medications:
- Current and/or past regular use of hormone-containing medications (excluding contraceptives)
- Use of medications such as oral corticosteroids which may have immunosuppressive effects.
- Current use of non-steroid anti-inflammatory drugs that is deemed by the investigators to potentially confound the results of the study (e.g. \> 3 days/week)
- Current and/or past regular use of immune modifying drugs that target specific immune responses such as TNF antagonists
- Current use of analgesics such as opioids or history of addiction to opioids or other analgesics
- Current and/or past regular use of cardiovascular medications, including antihypertensive, antiarrhythmic, anti-anginal, and anticoagulant drugs (does not apply where medications are taken for different purpose e.g...
- Chronic use of antibiotics such as isotretinoin or minocycline because of their potential effects on the microbiome and immune function.
- Evidence of recreational drug use from urine test.
- Lifetime use of methamphetamine
- Inclusion of individuals reporting other types of medications or supplements not listed or considered thus far will be at the discretion of the PI based on their potential to affect immune function, the microbiome...
- BMI \> 35 because of the effects of obesity on pro-inflammatory cytokine activity
- Clinically significant abnormalities on screening laboratory tests
- Abnormal EKG
- In addition, participants who on arrival to the study, show any of the following symptoms will not be allowed to complete the study:
- screening supine systolic blood pressure \>140 mmHg or \<100 mmHg
- screening supine diastolic blood pressure \>90 mmHg or \<60 mmHg
- 12-lead EKG demonstrating a PR interval \> 0.2 msec QTc \>450 or QRS \>120 msec (Bazett) If the QTc exceeds 450 msec, or QRS exceeds 120 msec, the EKG will be repeated 2 more times and the median value will be used
- pulse less than 50 beats/minute or greater than 100 beats/minute
- temperature greater than 99.5 degrees F. Non-English speaking participants:
- The majority of the assessments proposed for this study have not been translated from English, thus, non-English speaking volunteers will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.