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Valganciclovir for Depression

Laureate Institute for Brain Research, Tulsa, OK
DepressionValganciclovir - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Depression

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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X-TAU (xenon)
1
Ketamine
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Calcitriol

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 8 weeks

8 weeks
Anhedonia
CD8+ cells
Depression
Inflammatory mediators
Volume of the medial temporal gyrus (MTG)
Volume of the orbitofrontal cortex (OFC)
White matter integrity of the inferior fronto-occipital fasciculus (IFOF)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
X-TAU (xenon)
1
Ketamine
1
Calcitriol

Side Effects for

Valcyte
45%Leukopenia
15%CMV disease
15%BK infection
10%Acute rejection
10%Thrombocytopenia
5%Graft loss
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT01509404) in the Valcyte ARM group. Side effects include: Leukopenia with 45%, CMV disease with 15%, BK infection with 15%, Acute rejection with 10%, Thrombocytopenia with 10%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Valganciclovir
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: Valganciclovir · Has Placebo Group · Phase 1 & 2

Valganciclovir
Drug
Experimental Group · 1 Intervention: Valganciclovir · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valganciclovir
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
43 Previous Clinical Trials
4,958 Total Patients Enrolled
14 Trials studying Depression
2,328 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently experiencing symptoms of depression, as measured by a score of 14 or higher on a test called QIDS-SR.
You have been diagnosed with major depressive disorder (MDD).
You are between 18 and 65 years old, regardless of gender.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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