Actively Recruiting
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
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults
- Patients on a stable dose of selective serotonin uptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitors (SNRI) for at least 8 weeks
- Treatment-resistant generalized anxiety disorder defined by lack of response to at least two drugs from two different classes of first-line or second-line medications for GAD, with each trial lasting at least 8 weeks at minimum effective dose
You will not qualify if you...
- Moderate to severe major depressive disorder with a PHQ-9 score of 15 or above at baseline
- Moderate to high current suicidality or suicide likely in near future or current suicidal behavior disorder based on MINI 7.0
- Diagnosed with obsessive-compulsive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, epilepsy, or other severe neurological diseases
- Cardiovascular diseases, infections, inflammatory diseases, recent surgeries, recent physical trauma, or other medical issues that could elevate C-reactive protein or homocysteine
- Use of cannabis, cannabis by-products, illicit drugs, or alcohol over 3 drinks per week
- Use of vitamins or natural health products that may affect anxiety or depression symptoms
- Reading competence below Grade 5
- Lack of capacity to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
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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