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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: Recruiting Phase 1 study of Major Depressive Disorder, sponsored by Laureate Institute for Brain Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serum interleukin 6 (IL-6) (pg/mL)
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 |
What NCT04751331 shows while recruiting
NCT04751331 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (52% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04751331's enrollment target sits among peer trials
180 83rd of 282 higher than 198 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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