ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Description

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

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Study Overview

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Study Details

Study overview

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.

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

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Tulsa

Laureate Institute for Brain Research, Tulsa, Oklahoma, United States, 74136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Laureate Institute for Brain Research, Inc.,

Study Record Dates

2024-12