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L-methylfolate arm 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-week visit and 8-week visit.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Genitourinary
5%
Neurological
5%
Decreased energy
5%
Agitated/irritable
5%
Dermatological
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-Methylfolate
Placebo (for L-Methylfolate)

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
365 Previous Clinical Trials
120,407 Total Patients Enrolled
4 Trials studying Generalized Anxiety Disorder
375 Patients Enrolled for Generalized Anxiety Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it presently possible for individuals to participate in this clinical trial?

"According to the information provided on clinicaltrials.gov, this specific trial is no longer actively recruiting participants. Its initial posting date was April 1st, 2024 and it was last edited on January 11th, 2024. However, there are currently 424 other ongoing clinical trials that are open for patient enrollment at this time."

Answered by AI

What is the main objective of this medical study?

"The primary outcome of this clinical trial is the incidence of treatment-emergent side effects, which will be measured using the ASEC (Adverse Event Symptom Checklist). Secondary outcomes include remission, defined as a CGI-S score below 3 on the Clinical Global Impression - Severity scale. The CGI-S scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with a score of 0 indicating "not assessed." Additionally, changes in anxiety severity will be evaluated using the CGI-S scale by comparing scores at each visit. Anxiety symptom improvement will also be measured using the G"

Answered by AI

What are the potential risks associated with the administration of L-methylfolate to individuals?

"Given that this trial is categorized as Phase 4 and the treatment has already received approval, our team at Power rates the safety of the L-methylfolate arm with a score of 3."

Answered by AI

Is the age eligibility criteria for potential participants in this clinical trial limited to individuals above 30 years of age?

"To be eligible for participation in this trial, interested individuals must fall within the age range of 18 to 65. It is worth noting that there are currently 126 clinical trials specifically targeting patients under the age of 18 and an additional 269 trials focusing on those over the age of 65."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for enrollment in this medical study?

"In order to be eligible for this clinical trial, patients must have a diagnosis of generalized anxiety disorder and fall within the age range of 18 to 65. The study has capacity for a total of 10 individuals to participate."

Answered by AI

Who else is applying?

What site did they apply to?
Kingston Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
Dr. Rafael Freire 2024. "Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218030.
All > Anxiety Disorder
~7 spots leftby Mar 2025
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