RecruitingPhase 1Phase 2NCT04724447

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

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

Sponsor

Laureate Institute for Brain Research, Inc.

Enrollment

24 participants

Start Date

Nov 23, 2021

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an antiviral medication (valganciclovir, normally used to treat cytomegalovirus or CMV infection) can reduce symptoms of major depression. The idea is that CMV — a common virus that stays dormant in the body — may trigger inflammation that contributes to depression in some people. **You may be eligible if:** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression symptoms are currently significant (based on a symptom scale) - You have been off all antidepressants for at least 4 weeks (8 weeks for fluoxetine) - You are in good general health - You are willing to use contraception during and after the study **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have a serious medical condition such as heart disease, kidney disease, or a chronic infection like HIV - You have schizophrenia, bipolar disorder, or a severe substance use disorder - You have had a recent suicide attempt or have active suicidal thoughts - You are taking medications that interact with valganciclovir (a long list of antivirals, antibiotics, and cancer medications) - Your BMI is over 38 - You are not fluent in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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