L-methylfolate for Generalized Anxiety Disorder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Kingston Health Sciences Centre

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this feasibility study is to determine the tolerability and safety of add on treatment with L-methylfolate in patients with treatment-resistant generalized anxiety disorder (GAD). The primary objective is to monitor for side effects and other risks associated with the treatment. Secondary objectives are to compare the severity of symptoms, serum levels of folate, vitamin B12, C-reactive protein and homocysteine before and after treatment. Participants will continue with their usual treatment for GAD and receive add on treatment with L-methylfolate 15 mg per day for 8 weeks. All participants will receive the same intervention.

Research Team

Eligibility Criteria

This trial is for individuals with Generalized Anxiety Disorder (GAD) who haven't had success with their current treatments. Participants will continue their usual GAD treatment and also take L-methylfolate.

Inclusion Criteria

I am 18 years old or older.

I have been on a stable dose of SSRI or SNRI medication for at least 8 weeks.

My anxiety hasn't improved after trying two different recommended medications for at least 8 weeks each.

Exclusion Criteria

Reading competence below Grade 5

I am unable to understand or sign the consent form by myself.

I use vitamins or natural products that might impact my anxiety or depression.

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Treatment Details

Interventions

L-methylfolate (Other)

Trial OverviewThe study tests the safety and effectiveness of adding L-methylfolate to existing anxiety treatments. Patients will receive a daily dose of L-methylfolate alongside their regular medication for 8 weeks.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: L-methylfolate armExperimental Treatment1 Intervention

Oral administration of L-methylfolate 15 mg per day for 8 weeks.