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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02709668
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : March 29, 2016
Information provided by (Responsible Party):
B. Andrew Farah MD, FAPA, 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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Enlyte Other: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Clinical Response and Homocysteine Reduction Using Reduced B-Vitamin Therapy in MTHFR C677T/A1298C Patients With Major Depressive Disorder : an Analysis of Findings
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Placebo Comparator: placebo
gel cap with placebo
Other: placebo
identical to Enlyte
Other Name: inert gel cap

Experimental: enlyte
gel cap of B vitamins brand Enlyte
Dietary Supplement: Enlyte
gel cap of reduced B vitamins
Other Name: reduced B vitamins

Primary Outcome Measures :
  1. Homocysteine levels [ Time Frame: baseline and week 8 of study ]
    plasma homocysteine levels measured

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: baseline, week 2, week 8 ]
    standard measure of depression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Major depression with MTHFR positive status

Exclusion Criteria:

  • dementia, Bipolar, active substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02709668

Sponsors and Collaborators
High Point Regional Health Systems
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Principal Investigator: Arnold Mech, MD Mech Healthcare Associates

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: B. Andrew Farah MD, FAPA, chief of psychiatry high point div. of unc, High Point Regional Health Systems Identifier: NCT02709668    
Other Study ID Numbers: AMBFDepression
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by B. Andrew Farah MD, FAPA, High Point Regional Health Systems:
MTHFR depression vitamins Homocysteine
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs