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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.
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 moreSide effects data
From 2015 Phase 4 trial • 40 Patients • NCT0150940450%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding.I have other health issues like heart disease, stroke, Parkinson's, or chronic pain.You have had a serious problem with drug or alcohol abuse in the past year, except for cannabis or nicotine.You have a serious problem with alcohol.My overall health is good, as confirmed by recent medical exams and tests.I am a man who can father children and will use contraception during and for 3 months after the study.You are too afraid of small spaces to participate in the study.I can take pills and will follow the prescribed medication plan.You have any of the following: a cardiac pacemaker, metal fragments in your body, metal implants, shunts, metal plates/pins/screws/wires, or neuro/bio-stimulators. You have a history of eye surgery or vision problems that cannot be corrected. You are unable to lie still on your back for 60 minutes, have had neurosurgery, have tattoos or cosmetic makeup with metal dyes, refuse to remove body piercings, or are pregnant.If you are a woman who could become pregnant, you must use a very effective form of birth control for at least a month before starting the study and continue using it during the study and for four more weeks after the study ends.I am currently experiencing symptoms of depression.You have recently had an infection or received a vaccine within the last week.You are not willing to avoid getting pregnant during the study because the study drug, valganciclovir, can cause birth defects.My doctor will decide if my other medications or supplements affect my participation.My kidney function is reduced.You have signed a form that says you understand the study and agree to participate.You agree to follow all study procedures and be available for the entire study period.I have had a severe brain injury or a disorder affecting my brain function.You have tried to harm yourself within the last 6 months.You have been diagnosed with a certain type of mental illness that includes schizophrenia, delusional disorder, or schizoaffective disorder.I am not on long-term antibiotics like isotretinoin or minocycline.I am undergoing treatment that lowers my blood cell counts.I have a chronic infection that could cause inflammation.I have an autoimmune disorder like rheumatoid arthritis.I use NSAIDs more than 3 days a week, which might affect the study.I do not have thoughts about harming myself or planning suicide.I regularly use hormone medications, not including birth control.I use or have used drugs that change how my immune system works.I have been diagnosed with major depressive disorder.I am between 18 and 65 years old.I am fluent in English.You are pregnant.I use medication regularly for heart rhythm problems, chest pain, or blood thinning.You agree to follow instructions regarding your lifestyle during the entire study.You have a history of a manic or hypomanic episode that wasn't caused by drug use.I haven't taken any medication for the last 4 weeks, or 8 weeks if it was fluoxetine.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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