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

Launched by QUEEN'S UNIVERSITY · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether adding L-methylfolate, a form of folate (a vitamin), can help people with generalized anxiety disorder (GAD) who haven’t found relief with their current treatments. The study is focused on understanding how safe this treatment is and if it causes any side effects. Participants will continue taking their regular medication for anxiety, such as certain antidepressants, and will take an additional daily dose of L-methylfolate for 8 weeks. The researchers will check how participants feel during the study and measure some vitamins and other substances in their blood before and after the treatment.

To join the study, participants need to be adults who have been on a stable dose of certain anxiety medications for at least 8 weeks but still struggle with their symptoms. There are some important exclusions, such as having severe depression or other serious mental health issues, current suicidal thoughts, or certain medical conditions. If eligible, participants can expect to receive support and monitoring throughout the trial, helping researchers learn more about this potential treatment option for anxiety.

Gender

ALL

Eligibility 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.