Using L-methylfolate to help patients with treatment-resistant anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive JNJ-99245354 for Generalized Anxiety Disorder (GAD)

  This study tests whether adding JNJ-99245354 to existing GAD treatment helps reduce anxiety more than a placebo for adults with GAD who didn’t get adequate benefit from previous treatments.

  Recruiting at 4 sites Phase 3 Intra-Cellular Therapies, Inc. · Temecula, California and 3 other locations · NCT07856420

• Testing ITI-1284 for Generalized Anxiety Disorder (GAD)

  This phase 3 trial tests whether ITI-1284 is safe and tolerable when taken alone or with other medicines by adults with generalized anxiety disorder who haven’t responded to prior treatment.

  Recruiting at 3 sites Phase 3 Intra-Cellular Therapies, Inc. · Los Angeles, California and 2 other locations · NCT07807865

• Long-term safety and tolerability of SEP-363856 in adults with generalized anxiety disorder

  In adults with generalized anxiety disorder, this Phase 3 open-label extension tests whether continuing SEP-363856 at 50 mg or 75 mg daily for 26 weeks is safe, tolerable, and possibly helpful.

  Recruiting at 2 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Jacksonville, Florida and 1 other locations · NCT07786454

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

  This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.

  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• Continuous Theta Burst Stimulation for Generalized Anxiety Disorder (cTBS for GAD)

  This study tests whether applying continuous theta burst stimulation to the right posterior parietal cortex or the right dorsolateral prefrontal cortex helps adults with generalized anxiety disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07770919

• Fixed-dose SEP-363856 vs placebo for adults with generalized anxiety disorder

  This trial tests whether a fixed 75 mg/day dose of SEP-363856 helps adults with generalized anxiety disorder more than placebo over 8 weeks.

  Recruiting at 11 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Redlands, California and 10 other locations · NCT07767903

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.