Trial | NCT02709668  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    330
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.
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.
Study Started
Aug 31
2013
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Last Update
Mar 29
2016
Estimate

Dietary Supplement Enlyte

gel cap of reduced B vitamins

  • Other names: reduced B vitamins

Other placebo

identical to Enlyte

  • Other names: inert gel cap

placebo Placebo Comparator

gel cap with placebo

enlyte Experimental

gel cap of B vitamins brand Enlyte

Criteria 

Inclusion Criteria:

Major depression with MTHFR positive status

Exclusion Criteria:

dementia, Bipolar, active substance abuse
No Results Posted