Major Depressive Disorder
Conditions
Brief 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.
Interventions
DRUGValganciclovir
2 x 450mg VGCV tablets
DRUGPlacebo
Placebo equivalent of 900mg/day VGCV
Sponsors
Laureate Institute for Brain Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18-65 years 4. Diagnosis with major depressive disorder (MDD) 5. Current symptoms of depression, that is, a QIDS-SR score ≥14. 6. Unmedicated for at least 4 weeks (8 weeks for fluoxetine). 7. In good general health as evidenced by medical history, physical exam, and safety labs 8. Ability to take oral medication and be willing to adhere to the VGCV regimen 9. 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 10. 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. 11. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White matter integrity of the inferior fronto-occipital fasciculus (IFOF) | 8 weeks | Mean fractional anisotropy of the IFOF measured with diffusion tensor imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of the medial temporal gyrus (MTG) | 8 weeks | Mean gray matter volume of the MTG measured with structural MRI |
Countries
United States
Outcome results
None listed