Pilot Study of L-methylfolate Added to Usual Treatment for Adults With Treatment-Resistant Generalized Anxiety Disorder

What this Trial Is About

Researchers are evaluating the safety and tolerability of adding L-methylfolate to usual treatments in adults with treatment-resistant generalized anxiety disorder GAD. This pilot study focuses on monitoring side effects and risks while comparing symptom severity and blood markers like folate, vitamin B12, and inflammatory proteins before and after treatment. The study aims to explore whether folate supplementation can help patients who do not respond well to standard anxiety therapies. Participants will continue their current treatment with selective serotonin reuptake inhibitors SSRIs or serotonin-norepinephrine reuptake inhibitors SNRIs and receive an additional daily dose of 15 mg L-methylfolate by mouth for 8 weeks. All participants receive the same L-methylfolate treatment without a comparison group. The study does not involve blinding or placebo control. During the 8-week study, participants will attend visits at baseline, 4 weeks, and 8 weeks for assessments. Researchers will collect blood samples to measure folate, vitamin B12, C-reactive protein, homocysteine, tumor necrosis factor alpha, and interleukin 6 levels. They will evaluate anxiety symptoms using scales like GAD-7 and monitor treatment-emergent side effects throughout. The main outcomes include safety measures and response to treatment based on clinical global impression scores.

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