ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID: NCT04724447
Run by: Laureate Institute for Brain Research, Inc.
People needed: 20
Starts: 2021-11-23
Expected to finish: 2026-04-01
Last updated by the study team: 2026-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18-65 years
Diagnosis with major depressive disorder (MDD)
Current symptoms of depression, that is, a QIDS-SR score ≥14.
Unmedicated for at least 4 weeks (8 weeks for fluoxetine).
In good general health as evidenced by medical history, physical exam, and safety labs
Ability to take oral medication and be willing to adhere to the VGCV regimen
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of VGCV administration
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during the study and for at least 90 days after the study.
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

You may not qualify if…

General Exclusion Criteria:
Pregnancy
Breast-feeding
Unwillingness to avoid pregnancy during the study due to the possible teratogenic effects of valganciclovir
Medical Conditions:
Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
Presence of co-morbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders.
Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.
Presence of a chronic infection (e.g. HIV) that may elevate pro-inflammatory cytokines.
Presence of an acute infectious illness (e.g. SARS CoV-2) or receipt of a vaccination in the week prior to enrollment.
Psychiatric Disorders:
Current significant suicidal ideation (intent to commit suicide or making specific plans for suicide)
Suicide attempt within the last 6 months
Lifetime history of schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder
History of a manic or hypomanic episode not better accounted for by substance use
Moderate to severe substance use disorder within the last year, excluding cannabis or nicotine use disorder
Moderate or severe alcohol use disorder
Positive urine toxicology (except cannabis)
Contraindications to Valganciclovir:
Myelosuppressive chemotherapy or radiation therapy
Absolute neutrophil count < 500/mm3
Platelet count < 25,000/mm3
Hemoglobin < 8g/dL
Impaired renal function (estimated glomerular filtration rate <60mL/minute/1.73m2)

Where it is running

Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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