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

Trial Summary

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.

What is the purpose of this trial?

This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry, reduces inflammation, and improves depressive behavior and symptoms to a greater extent than placebo. In this double-blind, randomized placebo-controlled, parallel group trial, 24 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8-week treatment study. Participants will be randomized with a 1-1 ratio to receive 900 milligrams (mg) VGCV or placebo to be taken orally once per day. Participants will complete a 2-hour pre-screen, a baseline blood-draw, clinical evaluation, and MRI scan (visit 2), a clinical evaluation, blood draw, and MRI scan at week 4 (visit 6), and a clinical evaluation, blood draw, and MRI scan at week 8 (visit 10). Weekly telephonic visits to assess depressive symptoms and side effects will held between the in-person assessments.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+