Valganciclovir for Depression

Overseen By Jonathan Savitz, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Antibiotics, Antivirals, Immunosuppressants, others

Disqualifiers: Pregnancy, Cardiovascular, Neurological, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug valganciclovir can improve symptoms of major depressive disorder (MDD) in individuals who test positive for CMV, a common virus. Researchers aim to determine if this treatment can alter brain activity, reduce inflammation, and enhance mood more effectively than a placebo. Participants will take either the drug or a placebo daily for eight weeks, with regular check-ins to monitor progress. This trial may suit individuals diagnosed with MDD, experiencing current depressive symptoms, and not on medication for at least four weeks. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Participants must be unmedicated for at least 4 weeks (8 weeks for fluoxetine) and avoid specific medications that could interact with the trial drug, valganciclovir.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that valganciclovir has been safely used in various studies with healthy volunteers and patients with conditions like HIV and CMV (cytomegalovirus). However, some possible side effects should be noted. For instance, there is a risk of kidney problems, particularly in older adults with pre-existing kidney issues. Additionally, animal studies have suggested that valganciclovir might increase the risk of cancer, although this has not been proven in humans.

Safety reports from past clinical trials and real-world use indicate that the risks of valganciclovir remain consistent and manageable with careful monitoring. Discussing any concerns with a healthcare provider is crucial, especially when considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for depression, which typically include antidepressants like SSRIs and SNRIs, Valganciclovir is an antiviral medication that works differently by targeting viral infections possibly linked to depressive symptoms. Researchers are excited about this treatment because it explores the novel idea that certain depressive states might be influenced by viral activity, offering a new angle for treatment. This approach could potentially benefit patients who do not respond well to conventional antidepressants, providing an alternative pathway to manage symptoms.

What evidence suggests that valganciclovir might be an effective treatment for depression?

Studies have shown that valganciclovir effectively prevents and treats cytomegalovirus (CMV) infections, particularly in transplant patients. This antiviral treatment reduces CMV-related problems. In this trial, some participants will receive valganciclovir to explore its potential for treating depression. The idea stems from its ability to lower inflammation caused by CMV. Some research suggests a link between inflammation and depression, so this treatment could alleviate depressive symptoms. However, using valganciclovir specifically for depression remains under study, and more information is needed to confirm its effectiveness for this purpose. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

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

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 900 mg of valganciclovir or placebo orally once per day for 8 weeks

8 weeks

3 visits (in-person), weekly telephonic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Valganciclovir

Trial Overview 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.

How Is the Trial Designed?

Group I: Valganciclovir Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Valganciclovir is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Valcyte for:

• Cytomegalovirus (CMV) retinitis
• Prevention of CMV disease in organ transplant recipients

Approved in United States as Valcyte for:

• Cytomegalovirus (CMV) retinitis
• Prevention of CMV disease in organ transplant recipients

Approved in Canada as Valcyte for:

• Cytomegalovirus (CMV) retinitis
• Prevention of CMV disease in organ transplant recipients

Approved in Japan as Valcyte for:

• Cytomegalovirus (CMV) retinitis
• Prevention of CMV disease in organ transplant recipients

Approved in Switzerland as Valcyte for:

• Cytomegalovirus (CMV) retinitis
• Prevention of CMV disease in organ transplant recipients

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11959438/

Valacyclovir versus valganciclovir for cytomegalovirus ... The drugs demonstrate comparable efficacy in preventing CMV infection following kidney transplantation. However, ValA may have a lower impact on bone marrow ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04724447?term=valganciclovir%20hydrochloride&aggFilters=status:rec%20not%20act%20enr&country=United%20States&locStr=United%20States&viewType=Table&rank=6

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN ... This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29166336/

Long-term Results After 7 Years of a Randomized Clinical ... The VIPP study compared valganciclovir prophylaxis with preemptive treatment regarding efficacy, safety, and long-term graft outcome.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1404599

Valganciclovir for Symptomatic Congenital ... The treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at ...

5. openaccessjournals.com openaccessjournals.com/articles/valganciclovir-for-cytomegalovirus-prevention-and-treatment.pdf

Valganciclovir for cytomegalovirus prevention and treatment Studies have shown that it is effective for the prevention of CMV disease in high-risk (donor seropositive/recipient seronegative) solid-organ transplant ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf

VALCYTE (valganciclovir hydrochloride tablets) WARNING * Data were obtained from single and multiple dose studies in healthy volunteers, HIV-positive patients, and HIV-positive/CMV-positive patients ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/valganciclovir-oral-route/description/drg-20066642

Valganciclovir (oral route) - Side effects & dosage This medicine may cause kidney failure, especially in elderly patients with kidney problems. Check with your doctor right away if you have the ...

8. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c517a39-2ded-4c5a-8d56-276853414b31

valganciclovir tablet, film coated VALCYTE - DailyMed - NIH Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE has the potential to cause cancers in humans [see Warnings and Precautions (5.5)]. Close. 1 ...

9. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=390691b2-3db0-4b9f-934f-120674726f14

valganciclovir hydrochloride tablet, film coated - DailyMed - NIH Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans [see Warnings and Precautions (5.5) ]. Double ...

10. assets.roche.com assets.roche.com/f/173850/x/ad2abcc5b2/valcyte_pm_e.pdf

VALCYTE® (valganciclovir hydrochloride) Safety reports from the postmarketing setting are consistent with safety data from clinical trials with valganciclovir and ganciclovir (see ...