ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

  • STATUS
    Recruiting
  • End date
    Mar 26, 2024
  • participants needed
    24
  • sponsor
    Laureate Institute for Brain Research, Inc.
Updated on 26 March 2022

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.

Details
Condition Major Depressive Disorder
Treatment Placebo, Valganciclovir
Clinical Study IdentifierNCT04724447
SponsorLaureate Institute for Brain Research, Inc.
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
Sensitivity to VGCV, ganciclovir or other nucleoside analogues
Medications that could interact with VGCV (see below)
Prohibited Medications Abacavir Lamivudine, 3TC Amikacin Aminoglycosides Amphotericin
B cholesteryl sulfate complex (ABCD) Amphotericin B lipid complex (ABLC) Amphotericin
B liposomal (LAmB) Amphotericin B Aprotinin Bacitracin Bictegravir; Emtricitabine
Tenofovir Alafenamide Cisplatin Colchicine; Probenecid Cyclosporine Dapsone Darunavir
Cobicistat; Emtricitabine; Tenofovir alafenamide
Didanosine, ddI
Doravirine; Lamivudine; Tenofovir disoproxil fumarate Doxorubicin Efavirenz
Emtricitabine; Tenofovir Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide Elvitegravir
Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate Emtricitabine Emtricitabine
Rilpivirine; Tenofovir alafenamide Emtricitabine; Rilpivirine; Tenofovir disoproxil
fumarate Emtricitabine; Tenofovir alafenamide Emtricitabine; Tenofovir disoproxil
fumarate Entecavir Flucytosine Gentamicin Hyaluronidase, Recombinant; Immune Globulin
Hydroxyurea Imipenem; Cilastatin Immune Globulin IV, IVIG, IGIV Kanamycin Lamivudine
Tenofovir Disoproxil Fumarate Mycophenolate Paromomycin Pentamidine Plazomicin
Polymyxin B Streptomycin Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
Tacrolimus Talimogene Laherparepvec Telbivudine Tenofovir Alafenamide Tenofovir, PMPA
Tobramycin Trimethoprim Vancomycin Vinblastine Vinca alkaloids Vincristine Liposomal
Vincristine Vinorelbine Zidovudine
Other Medications
Current and/or past regular use of hormone-containing medications (excluding
contraceptives)
Current use of non-steroid anti-inflammatory drugs that is deemed by the
investigators to potentially confound the results of the study or the increase
risk of renal impairment (e.g. more than 3 days/week)
Current and/or past regular use of immune modifying drugs that target specific
immune responses such as TNF antagonists
Chronic use of antibiotics such as isotretinoin or minocycline because of their
potential effects on the microbiome and immune function
Current and/or past regular use of antiarrhythmic, anti-anginal, and
anticoagulant drugs (does not apply where medications are taken for different
purpose)
Inclusion of individuals reporting other types of medications or supplements not
listed or considered thus far will be at the discretion of the PI based on their
potential to affect immune function, brain function or brain blood flow
Contraindications to MRI
Cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm
clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart
valve replacement, shunt (ventricular or spinal), electrodes, metal
plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have
ever been a professional metal worker/welder, history of eye surgery/eyes washed
out because of metal, vision problems uncorrectable with lenses, inability to lie
still on one's back for 60 minutes; prior neurosurgery; tattoos or cosmetic
makeup with metal dyes, unwillingness to remove body piercings, and pregnancy
Claustrophobia severe enough to prevent scanning
Health Factors
BMI > 38 because of the effects of obesity on pro-inflammatory cytokine activity
Clinically significant abnormalities on screening laboratory tests
Non-English speaking participants
• The majority of the assessments proposed for this study have not been translated
from English, thus, non-English speaking volunteers will be excluded
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