What side effects are associated with this type of intervention?

Common treatments for depression include tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). TCAs can cause side effects such as dry mouth, constipation, tachycardia, palpitations, orthostatic hypotension, weight gain, blurred vision, and urinary retention. SSRIs, while generally better tolerated, can lead to side effects like nausea, insomnia, dizziness, dry mouth, and sexual dysfunction. Valganciclovir, an antiviral agent being studied for its potential benefits in CMV-positive individuals with depression, may cause side effects such as neutropenia, anemia, thrombocytopenia, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to make an informed decision about their treatment options.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and atypical antidepressants like bupropion. While Valganciclovir, an antiviral agent, is being studied for its potential effects on depression in CMV-positive individuals, it is not a standard treatment for depression. Traditional antidepressants remain the primary FDA-approved options for managing depressive symptoms.

What other types of research exist?

Currently, there are no specific novel alternatives to Valganciclovir mentioned for treating depression in CMV-positive patients. However, ongoing research into antiviral agents and their effects on neural circuitry and inflammation may yield new options in the future. Patients should consult their healthcare provider for the most up-to-date treatment options.

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Antiviral Agent

Valganciclovir for Depression

Phase 1 & 2

Recruiting

Research Sponsored by Laureate Institute for Brain Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication and be willing to adhere to the VGCV regimen

Current symptoms of depression, that is, a QIDS-SR score ≥14.

Must not have

Impaired renal function (estimated glomerular filtration rate <60mL/minute/1.73m2)

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Summary

This trial aims to find out if valganciclovir, a medication used to treat CMV, can also help treat major depressive disorder by reducing symptoms and inflammation.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial is testing if valganciclovir (VGCV) improves depression symptoms more effectively than a placebo in CMV+ individuals with MDD. It's an 8-week double-blind study where participants will receive either VGCV or placebo daily, along with regular clinical evaluations, blood draws, MRI scans, and weekly phone check-ins.See study design

What are the potential side effects?

Potential side effects of valganciclovir include but are not limited to headaches, nausea, diarrhea, vomiting, fever; less common ones may involve changes in mood or mental state such as confusion or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills and will follow the prescribed medication plan.

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I am currently experiencing symptoms of depression.

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I have been diagnosed with major depressive disorder.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced.

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I have had a severe brain injury or a disorder affecting my brain function.

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I am undergoing treatment that lowers my blood cell counts.

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I do not have thoughts about harming myself or planning suicide.

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I use or have used drugs that change how my immune system works.

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I am fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

White matter integrity of the inferior fronto-occipital fasciculus (IFOF)

Secondary outcome measures

Volume of the medial temporal gyrus (MTG)

Other outcome measures

Anhedonia

CD8+ cells

Depression

+2 more

Side effects data

From 2015 Phase 4 trial • 40 Patients • NCT01509404

50%

Leukopenia

30%

Acute rejection

25%

BK infection

20%

CMV disease

15%

Candidiasis

Thrombocytopenia

100%

80%

60%

40%

20%

Study treatment Arm

Valcyte Then Cytogam

Valcyte

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ValganciclovirExperimental Treatment1 Intervention

900 milligrams (mg) valganciclovir (VGCV) to be taken orally once per day for 8 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo equivalent of 900 milligrams (mg) VGCV to be taken orally once per day for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Valganciclovir

2019

Completed Phase 4

~2160

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression primarily include antidepressants that target monoaminergic systems, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs). These medications work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which are believed to improve mood and emotional state. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on their specific symptoms and biological responses. The trial studying Valganciclovir, an antiviral agent, explores a novel approach by targeting inflammation and neural circuitry alterations associated with cytomegalovirus (CMV) infection in depression, potentially offering new insights and treatment options for patients who do not respond to traditional antidepressants.

Ketamine as treatment for post-traumatic stress disorder: a review.The role of glutamatergic, GABA-ergic, and cholinergic receptors in depression and antidepressant-like effect.Drugs, genes and the blues: pharmacogenetics of the antidepressant response from mouse to man.