ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04724447
Study type	Interventional
Source	Laureate Institute for Brain Research, Inc.
Contact	Jonathan Savitz, PhD
Phone	918 502 5104
Email	jsavitz@laureateinstitute.org
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	November 23, 2021
Completion date	December 2024

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