Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-31 @ 6:22 PM
Study NCT ID:
NCT02615405
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks', 'timeFrame': 'Week 12'}, {'measure': 'Remission rate', 'timeFrame': 'Week 12'}, {'measure': 'Response rate', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Changes in Beck Depression Inventory (BDI)', 'timeFrame': 'Week 12'}, {'measure': 'Changes in Neurotoxicity Rating Scale (NRS)', 'timeFrame': 'Week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '28648567', 'type': 'DERIVED', 'citation': 'Su KP, Yang HT, Chang JP, Shih YH, Guu TW, Kumaran SS, Galecki P, Walczewska A, Pariante CM. Eicosapentaenoic and docosahexaenoic acids have different effects on peripheral phospholipase A2 gene expressions in acute depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Jan 3;80(Pt C):227-233. doi: 10.1016/j.pnpbp.2017.06.020. Epub 2017 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of physical illness in depression, the serotonin hypothesis seems to fail in approaching the etiology of depression. Based upon the evidence from epidemiological data, case-control studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved of depression.', 'detailedDescription': "There are several important questions to answer regarding phospholipid polyunsaturated fatty acids (PUFAs) hypothesis of depression. Firstly, although case-control studies revealed that depressive patients had lower levels of omega-3 PUFAs, the abnormal findings in individual PUFA of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or arachidonic acid (AA) are not consistent. Secondly, the deficits in n-3 PUFAs are related to their metabolic enzymes. However, the association study of polymorphisms of PUFA-metabolism related genes in depression is limited. Thirdly, the active component of antidepressant effect in n-3 PUFAs is still in debate. Fourthly, the molecular mechanisms of n-3 PUFAs' antidepressant effects have yet to be elucidated in human brain functional neuroimaging or in cellular models.\n\nThis 3-year proposal is divided into 2 clinical studies. In study 1, the investigators aim to test the clinical and biological effects of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind, placebo-controlled trial of patients with drug-free MDD. In study 2, the investigators will measure the biological and neuroimaging markers to investigate the biological mechanisms of EPA (3.5 g/d) versus DHA (1.75 g/d) in 12-week, double-blind, randomized-controlled trial with patients with drug-free major depression disorder (MDD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder\n* Age being age 18-65.\n* Capacity and willingness to give written informed consent.\n* Free from antidepressants, mood stabilizers, and antipsychotics for more than 4 weeks.\n\nExclusion Criteria:\n\n* Any major medical illnesses.\n* A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.'}, 'identificationModule': {'nctId': 'NCT02615405', 'briefTitle': 'Phospholipid Hypothesis of Depression: From Molecular Biology, Neuroimaging to Behaviour', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Science and Technology Council, Taiwan'}, 'orgStudyIdInfo': {'id': 'NSC101-2628-B-039-001-MY3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EPA', 'description': '3.5 g/day in Studies 1 \\& 2', 'interventionNames': ['Dietary Supplement: EPA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DHA', 'description': '1.75 g/day in Studies 1 \\& 2', 'interventionNames': ['Dietary Supplement: DHA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsules', 'description': 'oleic oil in Study 1', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'EPA', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish oil EPA'], 'description': 'A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 \\& 2.', 'armGroupLabels': ['EPA']}, {'name': 'DHA', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish oil DHA'], 'description': 'A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 \\& 2.', 'armGroupLabels': ['DHA']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['oleic oil'], 'description': 'A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.', 'armGroupLabels': ['Placebo capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403', 'city': 'Taichung', 'state': 'Taiwan', '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'}}}}