The methylation, neurotransmitter, and antioxidant connections between folate and depression.
Alan L Miller
https://pubmed.ncbi.nlm.nih.gov/18950248Actively Recruiting
Phase 4
Age: 18Years - 65Years
All Genders
ID06218030
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder A Pilot Study
Led by Queen's University · Updated on 2025-05-25
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults
- On a stable dose of an SSRI or SNRI for at least 8 weeks
- Treatment-resistant generalized anxiety disorder, defined by lack of response to at least two different drugs from first-line or second-line classes according to Canadian guidelines
- Only trials lasting at least 8 weeks with minimum effective doses count as failed trials
You will not qualify if you...
- Moderate to severe major depressive disorder (PHQ-9 score 15 or above)
- Moderate to high current suicidality or suicide likely soon based on MINI 7.0
- Diagnosis of OCD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, epilepsy or other severe neurological diseases
- Cardiovascular disease, infections, inflammatory diseases, recent surgeries or physical trauma that could elevate CRP or homocysteine
- Use of cannabis, cannabis by-products, illicit drugs, or alcohol above 3 drinks per week
- Use of vitamin supplements or natural health products affecting anxiety or depression
- Reading skills below grade 5
- Lack of capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive daily oral doses of L-methylfolate as an adjunct to their current treatment for generalized anxiety disorder.
3 visits (baseline, 4 weeks, and 8 weeks)
Trial Site Locations
Total: 1 location
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Published Research Related To This Trial
Association of vitamin B12 mediated hyperhomocysteinemia with depression and anxiety disorder: A cross-sectional study among Bhil indigenous population of India.
Kallur Nava Saraswathy, Shagufta Naaz Ansari, Gurjinder Kaur...
https://pubmed.ncbi.nlm.nih.gov/30904222Folate for depressive disorders: systematic review and meta-analysis of randomized controlled trials.
Matthew J Taylor, Stuart M Carney, Guy M Goodwin...
https://pubmed.ncbi.nlm.nih.gov/15260915