NCT04724447

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

EXPERIMENTAL ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION: AFFECTIVE, NEURAL, AND INFLAMMATORY MECHANISMS

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Valganciclovir	2 x 450mg VGCV tablets
DRUG	Placebo	Placebo equivalent of 900mg/day VGCV

Timeline

• Start date: 2021-11-23
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-01-26
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study