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L-methylfolate for Generalized Anxiety Disorder

Phase 4
Waitlist Available
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Participants who do not have capacity to conduct consent process
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-week visit and 8-week visit.
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test if adding L-methylfolate to the treatment of patients with treatment-resistant generalized anxiety disorder (GAD) is safe and well-tolerated. The main goal is to monitor

Who is the study for?
This trial is for individuals with Generalized Anxiety Disorder (GAD) who haven't had success with their current treatments. Participants will continue their usual GAD treatment and also take L-methylfolate.
What is being tested?
The study tests the safety and effectiveness of adding L-methylfolate to existing anxiety treatments. Patients will receive a daily dose of L-methylfolate alongside their regular medication for 8 weeks.
What are the potential side effects?
While monitoring for side effects is a primary goal, potential risks may include digestive discomfort, sleep disturbances, or allergic reactions specific to folate supplementation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or sign the consent form by myself.
Select...
My depression is moderate to severe, based on a PHQ-9 score of 15 or above.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-week visit and 8-week visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-week visit and 8-week visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent side effects measured with the ASEC
Response to treatment defined by CGI-I score below 3
Secondary study objectives
Change in anxiety severity measured by CGI-S
Change of anxiety symptoms measured with BAI
Change of anxiety symptoms measured with GAD-7
+6 more

Side effects data

From 2017 Phase 2 & 3 trial • 47 Patients • NCT01853280
77%
Headache
55%
Cold/Infection/Allergy
50%
Insomnia
36%
Musculoskeletal
32%
Decreased Appetite
27%
Mucosal Dryness
27%
Tense/Jittery
27%
Nausea/Vomit/Diarrhea
18%
Anxious/worried
14%
Cardiovascular
14%
Sad/down
14%
Sedation
5%
Neurological
5%
Agitated/irritable
5%
Decreased energy
5%
Dermatological
5%
Genitourinary
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-Methylfolate
Placebo (for L-Methylfolate)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: L-methylfolate armExperimental Treatment1 Intervention
Oral administration of L-methylfolate 15 mg per day for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-methylfolate
2016
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor
373 Previous Clinical Trials
124,056 Total Patients Enrolled
6 Trials studying Anxiety
596 Patients Enrolled for Anxiety
~3 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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