NCT02709668

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4 depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

March 7, 2016

Last Update Submit

March 28, 2016

Conditions

Depression

Keywords

MTHFR depression vitamins Homocysteine

Outcome Measures

Primary Outcomes (1)

  • Homocysteine levels

    plasma homocysteine levels measured

    baseline and week 8 of study

Secondary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale

    baseline, week 2, week 8

Study Arms (2)

placebo

PLACEBO COMPARATOR

gel cap with placebo

Other: placebo

enlyte

EXPERIMENTAL

gel cap of B vitamins brand Enlyte

Dietary Supplement: Enlyte

Interventions

EnlyteDIETARY_SUPPLEMENT

gel cap of reduced B vitamins

Also known as: reduced B vitamins
enlyte
placeboOTHER

identical to Enlyte

Also known as: inert gel cap
placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression with MTHFR positive status

You may not qualify if:

  • dementia, Bipolar, active substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mech AW, Farah A. Correlation of clinical response with homocysteine reduction during therapy with reduced B vitamins in patients with MDD who are positive for MTHFR C677T or A1298C polymorphism: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2016 May;77(5):668-71. doi: 10.4088/JCP.15m10166.

    PMID: 27035272DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Arnold Mech, MD

    Mech Healthcare Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of psychiatry high point div. of unc

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 16, 2016

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 29, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share