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

Depression Clinical Trial

— BVMD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709668
• Other study ID #: AMBFDepression
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2016
• Last updated: March 28, 2016
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: High Point Regional Health Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Major depression with MTHFR positive status

Exclusion Criteria:

• dementia, Bipolar, active substance abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Enlyte
gel cap of reduced B vitamins

Other:
• placebo
identical to Enlyte

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
High Point Regional Health Systems

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homocysteine levels	plasma homocysteine levels measured	baseline and week 8 of study	No
Secondary	Montgomery Asberg Depression Rating Scale	standard measure of depression	baseline, week 2, week 8	No