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Completed

NCT Number: NCT02709668

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major depression with MTHFR positive status

Exclusion criteria

  • dementia, Bipolar, active substance abuse

Treatment and study plan

Enlyte

Dietary Supplement

gel cap of reduced B vitamins

Other names: reduced B vitamins

Placebo

Other

identical to Enlyte

Other names: inert gel cap

Primary outcomes

  1. Homocysteine levels

    Time frame: baseline and week 8 of study

    plasma homocysteine levels measured

Secondary outcomes

  1. Montgomery Asberg Depression Rating Scale

    Time frame: baseline, week 2, week 8

    standard measure of depression

Sponsors and collaborators

Lead sponsor

High Point Regional Health Systems

Other

Registry information

Official study title

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

Acronym: BVMD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 16, 2016
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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