Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:48 PM
Study NCT ID:
NCT07363551
Status:
RECRUITING
Last Update Posted:
2026-01-26
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To investigate the effects of omega-3 in youth with depression'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical symptoms', 'timeFrame': 'week 0,1,2,4,8,12', 'description': 'Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level\n\n* 0-7: No depression / Normal\n* 8-13: Mild depression\n* 14-18: Moderate depression\n* 19-22: Severe depression -≥23: Very severe depression'}], 'secondaryOutcomes': [{'measure': 'gut microbiota', 'timeFrame': 'week 0,12', 'description': 'gut microbiota'}, {'measure': 'inflammatory cytokines (IL-6, hsCRP)', 'timeFrame': 'week 0,12', 'description': 'blood inflammatory cytokines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['omega-3, ADHD'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder', 'detailedDescription': 'This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder. Outcome measures including clinical symptoms, inflammation biomarkers and gut microbiota profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth with a DSM-5 diagnosis of MDE\n\nExclusion Criteria:\n\n* Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.\n* Allergic to omega-3 fatty acids'}, 'identificationModule': {'nctId': 'NCT07363551', 'acronym': 'OMIMYDep', 'briefTitle': 'Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CMUH109-REC3-129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'omega-3', 'description': 'EPA', 'interventionNames': ['Combination Product: Omega-3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'soy bean oil', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Omega-3 fatty acids', 'type': 'COMBINATION_PRODUCT', 'description': 'omega-3 fatty acids (EPA)', 'armGroupLabels': ['omega-3']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'soy bean oil', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'state': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Chen Chang, MD, Master', 'role': 'CONTACT', 'email': '013121@tool.caaumed.org.tw', 'phone': '886 4 22052121'}, {'name': 'Pei-Chen Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Psychiatrist', 'investigatorFullName': 'Pei-Chen Chang', 'investigatorAffiliation': 'China Medical University Hospital'}}}}