RecruitingPhase 4NCT06218030

Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study

PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study


Sponsor

Queen's University

Enrollment

10 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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, homocysteine, tumor necrosis factor alpha and interleukin 6 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding L-methylfolate (a form of the B vitamin folate) to standard antidepressant treatment improves outcomes in patients with depression that has not responded well to existing medications. L-methylfolate is thought to help the brain produce mood-regulating chemicals more effectively. **You may be eligible if...** - You have been diagnosed with major depressive disorder - Your depression has not adequately responded to at least one antidepressant - You are 18 or older - You are currently being treated with an antidepressant medication **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or active psychosis - You have a known allergy to folate or methylfolate supplements - You are currently using drugs or alcohol in a way that would interfere with the study - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL-methylfolate

Oral administration of L-methylfolate 15 mg per day for 8 weeks. The study drug will be given in addition to the standard of care (SOC) for GAD.


Locations(1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

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NCT06218030


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