Lipopolysaccharide (LPS) Challenge in Depression
Completed · Phase 1 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
LPS Challenge in Individuals with Major Depressive Disorder
Key facts
- Study ID
- NCT03142919
- Run by
- Laureate Institute for Brain Research, Inc.
- People needed
- 64
- Starts
- 2017-09-07
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2025-07-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 the depressed participants (N=50) will be required to have a high-sensitivity C-Reactive Protein (CRP) score of ≥3 mg/L, and half the participants will be required to have a CRP score of ≤1 mg/L.
- General Exclusion Criteria:
- Pregnancy
- Previous history of fainting during blood draws.
- Medical Conditions:
- A history of a head injury with loss of consciousness.
- 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
- Age of onset of depression >40 years
- Contraindications for MRI:
- Severe claustrophobia
- Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips.
- Medications:
- Current and/or past regular use of hormone-containing medications (excluding contraceptives)
- Current use of non-steroid anti-inflammatory drugs that is deemed by the investigators to potentially confound the results of the study
- 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
Where it is running
- Laureate Institute for Brain Research — Tulsa, Oklahoma, United States
Full record on ClinicalTrials.gov
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