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

NCT02709668 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-03-29

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Enlyte

gel cap of reduced B vitamins

OTHER

placebo

identical to Enlyte

Sponsors & Collaborators

  • High Point Regional Health Systems

    lead OTHER

Principal Investigators

  • Arnold Mech, MD · Mech Healthcare Associates

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02709668 on ClinicalTrials.gov