Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01620502
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2012-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-26', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2)', 'timeFrame': 'Weeks 0 to 24'}], 'secondaryOutcomes': [{'measure': 'Changes in Hamilton Depression Rating Scale (HDRS) (for Study 1); Response and remission rates (for Study 2)', 'timeFrame': 'Weeks 0 to 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Episode']}, 'referencesModule': {'references': [{'pmid': '24602409', 'type': 'DERIVED', 'citation': 'Su KP, Lai HC, Yang HT, Su WP, Peng CY, Chang JP, Chang HC, Pariante CM. Omega-3 fatty acids in the prevention of interferon-alpha-induced depression: results from a randomized, controlled trial. Biol Psychiatry. 2014 Oct 1;76(7):559-66. doi: 10.1016/j.biopsych.2014.01.008. Epub 2014 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients with IFN-induced depression.', 'detailedDescription': 'We have done a preliminary analysis in 63 HCV patients receiving IFN-α therapy enrolled in our current NSC project (NSC95-2320-B-039-037-MY3) and found that patients who later developed IFN-α-induced depression (case group, 21/63) had lower PUFA levels before starting IFN-α therapy than control group (p=0.024). In addition, there was a trend for a negative correlation (r=-0.224; p=0.078) between baseline DHA levels and the highest scores of BDI during IFN therapy in the whole group. These findings indicate that n-3 PUFAs might play a protective factor.\n\nThis 3-year proposal is divided into 2 clinical studies. In study 1, we aim to test the prophylactic effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for IFN-α-induced sickness behaviour and depressive symptoms, in a two-week, double-blind, placebo-controlled trial of 152 patients with HCV starting IFN-α therapy. In study 2, we will test the antidepressant effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) on IFN-α-induced depression during IFN-α therapy, in an eight-week, double-blind, placebo-controlled trial in 80 HCV patients who have already developed depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants will be adult patients with chronic HCV, assessed by hepatologists and then referred for IFN-α therapy and have capacity and willingness to give written informed consent\n\nExclusion Criteria:\n\n* Patients will be excluded if they have major depressive episode at assessment\n* Any history of pre-existing psychotic disorders (e.g. schizophrenia or bipolar disorder)\n* Alcohol or drug dependence within one year before entry into the study\n* Seizure disorders and evidence of any unstable substantial coexisting medical conditions (e.g. cardiovascular, endocrine, haematological, renal, or neurological diseases)'}, 'identificationModule': {'nctId': 'NCT01620502', 'briefTitle': 'N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Science and Technology Council, Taiwan'}, 'officialTitle': 'N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression', 'orgStudyIdInfo': {'id': 'NSC98-2628-B-039-020-MY3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EPA 3.5 g/day', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules', 'description': 'oleic oil', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acids']}, {'type': 'EXPERIMENTAL', 'label': 'DHA 1.75 g/day', 'description': 'DHA 1.75 g/day', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acids']}], 'interventions': [{'name': 'Omega-3 fatty acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Omega-3 PUFAs or fish oil'], 'description': 'A daily treatment of 5 identical capsules of EPA (3.5 g/d), DHA (1.75 g/d) or placebo (high oleic oil), in single or divided administration for 2 (Study 1) or 8 weeks (Study 2)', 'armGroupLabels': ['DHA 1.75 g/day', 'EPA 3.5 g/day', 'Placebo capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Kuan-Pin Su, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'China Medical University Hospital', 'investigatorFullName': 'Kuan-Pin', 'investigatorAffiliation': 'National Science and Technology Council, Taiwan'}}}}