Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-03-28 @ 4:35 PM
Study NCT ID:
NCT02709668
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2016-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homocysteine levels', 'timeFrame': 'baseline and week 8 of study', 'description': 'plasma homocysteine levels measured'}], 'secondaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': 'baseline, week 2, week 8', 'description': 'standard measure of depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MTHFR depression vitamins Homocysteine'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '27035272', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depression with MTHFR positive status\n\nExclusion Criteria:\n\n* dementia, Bipolar, active substance abuse'}, 'identificationModule': {'nctId': 'NCT02709668', 'acronym': 'BVMD', 'briefTitle': 'B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings', 'organization': {'class': 'OTHER', 'fullName': 'High Point Regional Health Systems'}, 'officialTitle': 'Clinical Response and Homocysteine Reduction Using Reduced B-Vitamin Therapy in MTHFR C677T/A1298C Patients With Major Depressive Disorder : an Analysis of Findings', 'orgStudyIdInfo': {'id': 'AMBFDepression'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'gel cap with placebo', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'enlyte', 'description': 'gel cap of B vitamins brand Enlyte', 'interventionNames': ['Dietary Supplement: Enlyte']}], 'interventions': [{'name': 'Enlyte', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['reduced B vitamins'], 'description': 'gel cap of reduced B vitamins', 'armGroupLabels': ['enlyte']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['inert gel cap'], 'description': 'identical to Enlyte', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arnold Mech, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mech Healthcare Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'High Point Regional Health Systems', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of psychiatry high point div. of unc', 'investigatorFullName': 'B. Andrew Farah MD, FAPA', 'investigatorAffiliation': 'High Point Regional Health Systems'}}}}