Valganciclovir for Depression
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications before joining the trial. Participants must be unmedicated for at least 4 weeks (8 weeks for fluoxetine) and avoid specific medications that could interact with the trial drug, valganciclovir.
What is the purpose of this trial?
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 Criteria
Adults aged 18-65 with major depressive disorder and a QIDS-SR score ≥14, who are in good health, have not taken medication for at least 4 weeks (8 weeks for fluoxetine), and can commit to the study's duration. Participants must use effective contraception and be willing to take oral medication as prescribed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 900 mg of valganciclovir or placebo orally once per day for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Valganciclovir
Valganciclovir is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
- Cytomegalovirus (CMV) retinitis
- Prevention of CMV disease in organ transplant recipients
- Cytomegalovirus (CMV) retinitis
- Prevention of CMV disease in organ transplant recipients
- Cytomegalovirus (CMV) retinitis
- Prevention of CMV disease in organ transplant recipients
- Cytomegalovirus (CMV) retinitis
- Prevention of CMV disease in organ transplant recipients
- Cytomegalovirus (CMV) retinitis
- Prevention of CMV disease in organ transplant recipients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laureate Institute for Brain Research, Inc.
Lead Sponsor