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NCT04724447 · ClinicalTrials.gov registry record · Phase 1
Antiviral Treatment OF Cytomegalovirus IN Depression
A Phase 1 study of Major Depressive Disorder, sponsored by Laureate Institute for Brain Research.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04724447 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 24 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04724447, 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
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry, reduces inflammation, and improves depressive behavior and symptoms to a greater extent than placebo. In this double-blind, randomized placebo-controlled, parallel group trial, 24 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8-week treatment study. Participants will be randomized with a 1-1 ratio to receive 900 milligrams (mg) VGCV or placebo to be taken orally once per day. Participants will complete a 2-hour pre-screen, a baseline blood-draw, clinical evaluation, and MRI scan (visit 2), a clinical evaluation, blood draw, and MRI scan at week 4 (visit 6), and a clinical evaluation, blood draw, and MRI scan at week 8 (visit 10). Weekly telephonic visits to assess depressive symptoms and side effects will held between the in-person assessments.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Valganciclovir
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04724447
The ClinicalTrials.gov registry entry for NCT04724447 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% 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 Placebo is the first listed.
NCT04724447 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04724447 about?
NCT04724447 is a clinical study titled "Antiviral Treatment OF Cytomegalovirus IN Depression". This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry, reduces inflammation, and improves depressive behavior and symptoms to a greater extent than placebo. In this double-blind, rando...
What is the current status of trial NCT04724447?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-11-23. Estimated completion is 2026-12.
What conditions does trial NCT04724447 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04724447?
The interventions under investigation include: Placebo (DRUG), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT04724447?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04724447 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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Related
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