Using L-methylfolate to help patients with treatment-resistant anxiety
PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
This study is testing if adding L-methylfolate to the usual anxiety medications can help people with treatment-resistant generalized anxiety disorder feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06218030 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and tolerability of L-methylfolate as an adjunctive treatment for patients suffering from treatment-resistant generalized anxiety disorder (GAD). Participants will continue their usual treatment with SSRIs or SNRIs while receiving 15 mg of L-methylfolate daily for 8 weeks. The study will monitor side effects and assess changes in anxiety symptoms and various biomarkers before and after treatment. The goal is to determine if L-methylfolate can enhance treatment outcomes for those who have not responded to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults with treatment-resistant GAD who have been on a stable dose of SSRIs or SNRIs for at least 12 weeks.
Not a fit: Patients with moderate to severe major depressive disorder or significant suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with treatment-resistant generalized anxiety disorder, potentially improving their symptoms and quality of life.
How similar studies have performed: Previous studies have shown that adjunctive folate treatments can improve outcomes in major depressive disorder, suggesting potential for success in this context as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults. * Patients on a stable dose of an selective serotonin uptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitors (SNRI) for at least 8 weeks. * Treatment-resistant GAD, defined by lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD according to the Canadian Clinical Practice Guidelines for the Management of Anxiety, Posttraumatic Stress and Obsessive-Compulsive Disorders (Katzman et al., 2014). Only trials lasting at least 8 weeks and with at least the minimum effective dose of the given medication will be considered failed trials. Exclusion Criteria: * Patients with moderate to severe major depressive disorder based on the Patient Health Questionnaire - Nine Item (PHQ-9) scale (score of 15 or above) at baseline. * Mini International Neuropsychiatric Interview version (MINI) 7.0 indicates moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder. * Patients diagnosed with obsessive-compulsive disorder (OCD), bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, epilepsy or other severe neurological diseases. * Patients with cardiovascular diseases, infections, inflammatory diseases, recent surgeries, recent physical trauma and other medical issues that could produce elevation of c-reactive protein (CRP) or homocysteine. * Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week. * Supplementation of diet with vitamins or consumption of natural health products that may affect anxiety or depression symptoms. * Reading competence below Grade 5. * Participants who do not have capacity to conduct consent process.
Where this trial is running
Kingston, Ontario
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.