Generalized Anxiety Disorder Clinical Trial
Official title:
PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study
Verified date | January 2024 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Miller AL. The methylation, neurotransmitter, and antioxidant connections between folate and depression. Altern Med Rev. 2008 Sep;13(3):216-26. — View Citation
Saraswathy KN, Ansari SN, Kaur G, Joshi PC, Chandel S. Association of vitamin B12 mediated hyperhomocysteinemia with depression and anxiety disorder: A cross-sectional study among Bhil indigenous population of India. Clin Nutr ESPEN. 2019 Apr;30:199-203. doi: 10.1016/j.clnesp.2019.01.009. Epub 2019 Feb 12. — View Citation
Taylor MJ, Carney SM, Goodwin GM, Geddes JR. Folate for depressive disorders: systematic review and meta-analysis of randomized controlled trials. J Psychopharmacol. 2004 Jun;18(2):251-6. doi: 10.1177/0269881104042630. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events | Monitor participants for treatment-emergent adverse events and serious adverse events. | Throughout the study, 8 weeks | |
Primary | Incidence of treatment-emergent side effects measured with the ASEC | Monitor participants for minor treatment-emergent side effects measured with the Antidepressant Side-Effect Checklist (ASEC).
ASEC is a list of 21 possible side effects from antidepressants. Each item is rated from 0 (absent) to 3 (severe). |
Baseline visit, 4-week visit and 8-week visit. | |
Primary | Response to treatment defined by CGI-I score below 3 | Response to treatment, which will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement (CGI-I) scale.
CGI-I is a clinician administered one-item clinical scale rated from 1 (very much improved) to 7 (very much worse). Not assessed would confer score 0. |
4-week visit and 8-week visit. | |
Secondary | Remission defined by CGI-S score below 3 | Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity (CGI-S) scale.
CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0. |
4-week visit and 8-week visit. | |
Secondary | Change in anxiety severity measured by CGI-S | Changes in scores for CGI-S by comparing the scores in each visit. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0. | Baseline visit, 4-week visit and 8-week visit. | |
Secondary | Change of anxiety symptoms measured with GAD-7 | Changes in scores for Generalized Anxiety Disorder 7-item scale (GAD-7) by comparing the scores in each visit.
GAD-7 is a self-rated 7-item scale, each item is rated from 0 (not at all) to 3 (nearly every day). |
Baseline visit, 4-week visit and 8-week visit. | |
Secondary | Change of anxiety symptoms measured with PSWQ | Changes in scores for Penn State Worry Questionnaire (PSWQ) by comparing the scores in each visit.
PSWQ is a self-rated 16-item scale, each item is rated from 1 (not at all typical of me) to 5 (very typical of me). |
Baseline visit, 4-week visit and 8-week visit. | |
Secondary | Change of anxiety symptoms measured with BAI | Changes in scores for Beck Anxiety Inventory (BAI) by comparing the scores in each visit.
BAI is a self-rated 21-item scale, each item is rated from 0 (not at all) to 3 (severely - it bothered me a lot). |
Baseline visit, 4-week visit and 8-week visit. | |
Secondary | Concentration of CRP in serum | Collection of blood sample and measurement of the concentration of C-Reactive Protein (CRP) in serum. | Baseline visit and 8-week visit. | |
Secondary | Concentration of homocysteine in serum | Collection of blood sample and measurement of the concentration of homocysteine in serum. | Baseline visit and 8-week visit. | |
Secondary | Concentration of vitamin B12 in serum | Collection of blood sample and measurement of the concentration of vitamin B12 in serum. | Baseline visit and 8-week visit. | |
Secondary | Concentration of folate in serum | Collection of blood sample and measurement of the concentration of folate in serum. | Baseline visit and 8-week visit. |
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