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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
In good general health as evidenced by medical history, physical exam, and safety labs
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study 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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My overall health is good, as confirmed by recent medical exams and tests.
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I am a man who can father children and will use contraception during and for 3 months after the study.
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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.
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I haven't taken any medication for the last 4 weeks, or 8 weeks if it was fluoxetine.

Timeline

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
5%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,321 Total Patients Enrolled
18 Trials studying Depression
2,657 Patients Enrolled for Depression

Media Library

Valganciclovir (Antiviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04724447 — Phase 1 & 2
Depression Clinical Trial 2023: Valganciclovir Highlights & Side Effects. Trial Name: NCT04724447 — Phase 1 & 2
Valganciclovir (Antiviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04724447 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary applications does Valganciclovir demonstrate efficacy for?

"Valganciclovir has been employed to treat cytomegalovirus retinitis, as well as kidney and cardiac transplant infections and other related cytomegalovirus illnesses."

Answered by AI

Is the enrollment criteria of this trial inclusive of individuals aged 20 and above?

"This clinical trial is looking for volunteers 18 to 65 years of age. For younger patients, there are 108 trials and older participants have access to 606 different studies."

Answered by AI

Can individuals currently enroll in this trial?

"Affirmative. Information visible on clinicaltrials.gov confirms that this trial, first posted November 23rd 2021, is currently recruiting participants. 24 patients need to be enrolled at 1 site."

Answered by AI

Could I potentially partake in this clinical experiment?

"This clinical trial is recruiting 24 individuals between the ages of 18 and 65 who have been diagnosed with involutional psychosis. In addition to this criteria, male participants must use contraception for 90 days after the study ends and all patients must be off medication for at least 4 weeks (8 in the case of fluoxetine). Furthermore, it is required that potential participants demonstrate symptoms of depression as demonstrated by a QIDS-SR score ≥14 and commit themselves to comply with procedures throughout the duration of the experiment."

Answered by AI

How many volunteers are accepted for participation in this clinical trial?

"Affirmative. Records hosted on clinicaltrials.gov verify that this research project, first shared on November 23rd 2021, is still in the process of recruiting participants. 24 individuals must be enrolled from a single medical centre for successful completion of the study."

Answered by AI

Who else is applying?

What site did they apply to?
Laureate Institute for Brain Research
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried almost every medications and still have major depression.
PatientReceived 2+ prior treatments
~5 spots leftby Dec 2024