Clinical trial NCT02709668: B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: MTHFR depression vitamins Homocysteine
Lead sponsor: High Point Regional Health Systems
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: Inclusion Criteria:

* Major depression with MTHFR positive status

Exclusion Criteria:

* dementia, Bipolar, active substance abuse

Primary outcomes:
measure: Homocysteine levels
timeFrame: baseline and week 8 of study
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: baseline, week 2, week 8
Other outcomes:
Locations:
Study officials:
affiliation: Mech Healthcare Associates
name: Arnold Mech, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.