Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated May 25, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-01-11; most recent amendment 2025-05-21.
Status change: Not Yet Recruiting → Recruiting 2025-04-04
Trial Details
NCT Number NCT06218030
Lead Sponsor Queen's University
Conditions Generalized Anxiety Disorder
Enrollment 10 participants
Start Date 2024-10-22
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-25