Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 2:55 PM
Study NCT ID:
NCT01235533
Status:
COMPLETED
Last Update Posted:
2010-11-05
First Post:
2010-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Oil Supplementation in Late-life Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D005395', 'term': 'Fish Oils'}], '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': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-04', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of depression', 'timeFrame': 'week 8, 16, 24, 32, 40, 48', 'description': 'Definition of recurrence of depression (between last visit and current visit):\n\n1. Fulfilled diagnosis of major depressive episode according to DSM-IV-TR\n2. Score of sucide subscale in 17-item Hamilton Depression Rating was 3 or over\n3. Hospitalization due to depression'}], 'secondaryOutcomes': [{'measure': 'Change of cognitive function', 'timeFrame': 'Week 48', 'description': 'Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['late-life depression', 'recurrence of depression', 'cognition', 'N-3 polyunsaturated fatty acids'], 'conditions': ['Late-Life Depression']}, 'referencesModule': {'references': [{'pmid': '34817851', 'type': 'DERIVED', 'citation': 'Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.', 'detailedDescription': "Patients with late-life depression were reported cognitive impairment, especially in information-processing speed, working memory, attention and episodic memory, even after depressive symptoms subside and some of them further progress to dementia in two to four years. Several epidemiological studies, fatty acid comparison studies, animal studies, and clinical trials found that omega-3 polyunsaturated fatty acids (PUFAs) were significantly associated with the major depression, cognitive decline in general population and Alzheimer's disease. Until now, there is no study investigating the effects of n-3 PUFAs on depressive symptoms and cognition in patients with late-life depression. Thus, the aims of this study were to investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* An age range of 60 years old or over;\n* A previous diagnosis of major depressive disorder according to the Chinese version of Structured Clinical Interview for DSM IV-TR Axis-I Disorder;\n* Depressive symptoms were stable for at least three consecutive weeks and the 17-item Hamilton Depression Rating Scale score less or equal to 10.\n* Capacity to provide informed consent.\n\nExclusion Criteria:\n\n* People with severe or acute medical illness ( such as metastatic cancer, brain tumor, decompensated cardiac, hepatic, or renal failure, or myocardial infarction or stroke) within the 3 months preceding the study.\n* Those who had neurological disorders involving central nervous system, such as delirium, Parkinson's disease, aphasia or multiple sclerosis)\n* Prominent cognitive impairment, defined as the Chinese version of Mini-Mental State examination score less than 17.\n* People with alcoholism, defined by a score of 8 or higher in male and of 6 or higher in female on the Chinese version of the Alcohol Use Disorders Identification Test (AUDIT) questionnaire."}, 'identificationModule': {'nctId': 'NCT01235533', 'briefTitle': 'Fish Oil Supplementation in Late-life Depression', 'organization': {'class': 'OTHER', 'fullName': 'Taipei City Psychiatric Center, Taiwan'}, 'officialTitle': 'The Assessment for the Effects of Health Products on Depression and Cognitive Function:Fish Oil in Patients With Late-life Depression', 'orgStudyIdInfo': {'id': '95004-62-161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-3 fatty acids', 'description': 'Participants in this arm were received three capsules of n-3 fatty acids. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g。', 'interventionNames': ['Dietary Supplement: N-3 polyunsaturated fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm were received three identical capsules per day. All capsules included olive oil.', 'interventionNames': ['Dietary Supplement: N-3 polyunsaturated fatty acids']}], 'interventions': [{'name': 'N-3 polyunsaturated fatty acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish oil'], 'description': 'Three capsules per day. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g.', 'armGroupLabels': ['N-3 fatty acids', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chih-Chiang Chiu', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Psychiatry, Cathay General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'CHIH-CHIANG CHIU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Psychiatric Center, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'CHIH-CHIANG CHIU', 'oldOrganization': 'Taipei City Psychiatric Center, Taipei City Hospital'}}}}