Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT00226356
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Supplements for Unipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001622', 'term': 'Betaine'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms'}]}, 'conditionsModule': {'conditions': ['Unipolar Depression']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.', 'detailedDescription': 'The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS \\> 18; women of reproductive potential must use an acceptable method of birth control\n\nExclusion Criteria:\n\n* Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy'}, 'identificationModule': {'nctId': 'NCT00226356', 'briefTitle': 'Natural Supplements for Unipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge Health Alliance'}, 'officialTitle': 'Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-carbon Cycle With L-methionine, Betaine and Folate', 'orgStudyIdInfo': {'id': 'CHA-IRB-0048/04/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplements of L-methionine, betaine and folate', 'interventionNames': ['Drug: Supplements of L-methionine, betaine and folate']}], 'interventions': [{'name': 'Supplements of L-methionine, betaine and folate', 'type': 'DRUG', 'armGroupLabels': ['Supplements of L-methionine, betaine and folate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cambridge Health Alliance', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Robert T Dunn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge Health Alliance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge Health Alliance', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Alliance for Research on Schizophrenia and Depression', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}