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B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings

Clinical Response and Homocysteine Reduction Using Reduced B-Vitamin Therapy in MTHFR C677T/A1298C Patients With Major Depressive Disorder : an Analysis of Findings

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02709668
Acronym
BVMD
Enrollment
330
Registered
2016-03-16
Start date
2013-08-31
Completion date
2014-04-30
Last updated
2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

MTHFR depression vitamins Homocysteine

Brief summary

A randomized double-blind placebo controlled study of reduced B vitamins in patients with major depression who were positive for one or both of the common MTHFR polymorphisms was conducted between 8/1/2014 and 4/3/2015. Homocysteine levels and MADRS scores were used as primary measures. The study was designed to test safety and efficacy of reduced B vitamins in MDD associated with MTHFR. This study examines the data from the trial to see effects, effect sizes, and further, if demographic factors and other patient characteristics correlated with findings.

Detailed description

This original study was designed to evaluate the efficacy and safety of reduced B vitamins as monotherapy in adults with major depressive disorder (MDD) who were also positive for at least 1 methylenetetrahydrofolate reductase (MTHFR) polymorphism associated with depression, and further test the hypothesis that reduced (metabolized) B vitamins will lower homocysteine (HCY) in a majority of clinically responding patients. 330 adult patients with MDD (DSM-5), and positive for MTHFR C677T and/or A1298C polymorphisms were enrolled in a trial conducted between August 1, 2014, and April 3, 2015. 160 patients received placebo, while 170 received a capsule containing a combination of reduced B vitamins. Plasma homocysteine levels were measured at baseline and week 8. The Montgomery-Asberg Depression Rating Scale (MADRS) was used to evaluate efficacy for MDD. This further analysis is conducted on the resultant data, with patient names withheld. It is an extensive look at the findings to determine if response is correlated with HCY reduction and if other factors may be associated with response or non-response.

Interventions

DIETARY_SUPPLEMENTEnlyte

gel cap of reduced B vitamins

OTHERplacebo

identical to Enlyte

Sponsors

High Point Regional Health Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Major depression with MTHFR positive status

Exclusion criteria

* dementia, Bipolar, active substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Homocysteine levelsbaseline and week 8 of studyplasma homocysteine levels measured

Secondary

MeasureTime frameDescription
Montgomery Asberg Depression Rating Scalebaseline, week 2, week 8standard measure of depression

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026