Status:
RECRUITING
ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 imp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- General
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04724447
Start Date
November 23 2021
End Date
December 1 2026
Last Update
March 4 2025
Active Locations (1)
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1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136