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NCT04751331 · ClinicalTrials.gov registry record · Phase 1
Neural Response to Inflammatory Challenge in Major Depressive Disorder
A Phase 1 study of Major Depressive Disorder, sponsored by Laureate Institute for Brain Research.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT04751331 is a Phase 1 study of Major Depressive Disorder that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 180 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04751331, a Phase 1 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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 body weight) or placebo (same volume of 0.9% saline) administered as an intravenous bolus. This will yield the following groups: MDD-LPS (n=60), MDD-Placebo (n=30), HC-LPS (n=60), HC-placebo (n=30). There are three main aims: to identify immune pathways and neural circuits that respond differently to LPS in MDD vs. HC subjects; (2) to test whether the strength of inflammatory changes induced by LPS is associated with degree of change in anhedonic symptoms and neural circuits in the MDD group, and (3) to identify a biotype of MDD that shows a differential immunological and neurophysiological response to LPS. The main outcome variables are symptoms of anhedonia measured with the Snaith-Hamilton Pleasure Scale (SHAPS), cytokines (Il-6, IL-8, IL-10, and TNF), and BOLD signal change in the neural circuitry mediating interoceptive processing, i.e. the insula and cingulate cortex. The exploratory aim is to determine whether the acute inflammatory response to LPS can predict the clinical course of depression over a period of six months. The main outcome of this component of the study is self-reported depressive symptoms assessed with the QIDS-SR.
Conditions Studied
Interventions
- BIOLOGICAL LPS
- BIOLOGICAL Saline
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04751331
The ClinicalTrials.gov registry entry for NCT04751331 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (52% lower). The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which LPS is the first listed.
NCT04751331 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04751331 about?
NCT04751331 is a clinical study titled "Neural Response to Inflammatory Challenge in Major Depressive Disorder". 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. This will ...
What is the current status of trial NCT04751331?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2021-05-15. Estimated completion is 2027-09.
What conditions does trial NCT04751331 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04751331?
The interventions under investigation include: LPS (BIOLOGICAL), Saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT04751331?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04751331 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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