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

Phase 4

Completed

• Conditions: Depression
• Interventions: Other: placebo; Dietary Supplement: Enlyte

• Registration Number: NCT02709668
• Lead Sponsor: High Point Regional Health Systems

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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-16
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Major depression with MTHFR positive status

Exclusion Criteria

• dementia, Bipolar, active substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	gel cap with placebo
enlyte	Enlyte	gel cap of B vitamins brand Enlyte

Primary Outcome Measures

Name	Time	Method
Homocysteine levels	baseline and week 8 of study	plasma homocysteine levels measured

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale	baseline, week 2, week 8	standard measure of depression