Status:
RECRUITING
Neural Response to Inflammatory Challenge in Major Depressive Disorder
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 b...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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 MINI International Neuropsychiatric Interview and current symptoms of depression will be measured with the clinician-administered MADRS and the self-report PHQ-9. Depressed participants will be required to have symptoms of depression (i.e. a PHQ-9 score ≥10) and/or a MADRS score of ≥7.
Exclusion
- General
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04751331
Start Date
May 15 2021
End Date
September 1 2027
Last Update
March 4 2025
Active Locations (1)
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1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136