- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709668
B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings (BVMD)
March 28, 2016 updated by: B. Andrew Farah MD, FAPA, High Point Regional Health Systems
Clinical Response and Homocysteine Reduction Using Reduced B-Vitamin Therapy in MTHFR C677T/A1298C Patients With Major Depressive Disorder : an Analysis of Findings
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
330
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Major depression with MTHFR positive status
Exclusion Criteria:
- dementia, Bipolar, active substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
gel cap with placebo
|
identical to Enlyte
Other Names:
|
Experimental: enlyte
gel cap of B vitamins brand Enlyte
|
gel cap of reduced B vitamins
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Homocysteine levels
Time Frame: baseline and week 8 of study
|
plasma homocysteine levels measured
|
baseline and week 8 of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery Asberg Depression Rating Scale
Time Frame: baseline, week 2, week 8
|
standard measure of depression
|
baseline, week 2, week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arnold Mech, MD, Mech Healthcare Associates
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
March 7, 2016
First Submitted That Met QC Criteria
March 10, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Estimate)
March 29, 2016
Last Update Submitted That Met QC Criteria
March 28, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMBFDepression
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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