Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218030
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-12-19
Brief Title:
Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder a Pilot Study
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
PSIY-744-23 Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 primary objective is to monitor for side effects and other risks associated with the treatment Secondary objectives are to compare the severity of symptoms serum levels of folate vitamin B12 C-reactive protein and homocysteine before and after treatment Participants will continue with their usual treatment for GAD and receive add on treatment with L-methylfolate 15 mg per day for 8 weeks All participants will receive the same intervention
Detailed Description:
Background Up to 337 of the population are affected by an anxiety disorder during their lifetime according to large populationbased surveys Generalized anxiety disorder GAD has a lifetime prevalence of 28 to 62 in these studies GAD is associated with functional occupational and quality of life impairments Certain types of medications and psychotherapies are established treatments for GAD but only 50 of the patients respond to the first treatment trial Deficiency of folates and neuroinflammation are two hypothesis that could explain why some patients with anxiety disorders do not respond to the usual treatments Supplementation with folates could correct these deficiencies and reduce inflammation thus increasing the success rates for treatments In studies with major depressive disorder adjunctive folates were associated to higher remission rates Other studies indicate that folate supplementation lowers homocysteine levels and inflammation Objectives Ascertain if adjunctive treatment with Lmethylfolate can produce improvement in treatment-resistant GAD subjects Methods This is a proof-of-concept pilot study an open-label trial of adjunctive treatment with L-methylfolate in patients with treatment-resistant GAD Ten adult patients with treatment-resistant GAD who have been on a stable dose of an SSRI or SNRI for at least 12 weeks will receive 15 mg doses of L-methylfolate daily for 8 weeks Patients with moderate to severe major depressive disorder or suicide risk will not be included Serum levels of folate vitamin B12 C-reactive protein and homocysteine will be measured before and after the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None