Status:
RECRUITING
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
Lead Sponsor:
Queen's University
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 prim...
Detailed Description
Background: Up to 33.7% of the population are affected by an anxiety disorder during their lifetime according to large populationbased surveys. Generalized anxiety disorder (GAD) has a lifetime preval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06218030
Start Date
October 22 2024
End Date
May 1 2026
Last Update
May 25 2025
Active Locations (1)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7